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Ad26.Mos4.HIV

Phase 3

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: May 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment4,055
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03964415A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender IndividualsPHASE3 COMPLETED 3,900Oct 31, 2019Aug 10, 2023Jul 31, 202453 United States, Argentina +7
NCT02935686A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected AdultsPHASE1 COMPLETED 155Mar 31, 2017Nov 22, 2023May 25, 202513 United States, Kenya +1
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Study Endpoints
Primary Endpoints
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set)
From Month 7 up to Month 24

Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.

Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set)
From Month 7 up to Month 30

Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.

Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1
Up to 7 days post-vaccination 1 on Day 1 (up to Day 8)

Number of participants with solicited local and systemic AEs for 7 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.

Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2
Up to 7 days post vaccination 2 (up to any day from Day 78 to Day 113) (vaccination 2 ranged from Day 78 to 106)

Number of participants with solicited local and systemic AEs for 7 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.

Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3
Up to 7 days post vaccination 3 (up to any day from Day 162 to Day 197) (vaccination 3 ranged from Day 162 to 190)

Number of participants with solicited local and systemic AEs for 7 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.

Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4
Up to 7 days post vaccination 4 (up to any day from Day 330 to Day 365) (vaccination 4 ranged from Day 330 to 358)

Number of participants with solicited local and systemic AEs for 7 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.

Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1
Up to 28 days post-vaccination 1 on Day 1 (Up to Day 29)

Number of participants with unsolicited AEs for 28 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2
Up to 28 days post vaccination 2 (up to any day from Day 78 to Day 134) (vaccination 2 ranged from Day 78 to 106)

Number of participants with unsolicited AEs for 28 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3
Up to 28 days post vaccination 3 (up to any day from Day 162 to Day 218) (vaccination 3 ranged from Day 162 to 190)

Number of participants with unsolicited AEs for 28 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4
Up to 28 days post vaccination 4 (up to any day from Day 330 to Day 358) (vaccination 4 ranged from Day 330 to 358)

Number of participants with unsolicited AEs for 28 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs
From Baseline (Day 1) up to Week 72

Number of participants who discontinued study vaccination due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.

Main Study: Number of Participants With Serious Adverse Events (SAEs)
From Baseline (Day 1) up to Week 72

Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs)
From Baseline (Day 1) up to Week 216

Number of participants with adverse events of special interest (AESIs) were reported. As planned, confirmed HIV infection was the only event assessed as an AESI. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (that is, serious and nonserious AEs) or causality.

Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs
From Week 188 up to end of study (Week 288)

Number of participants who discontinued study due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.

Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination
Up to 7 days post late boost vaccination (up to any day from Day 1317 to Day 1464) (late boost vaccination ranged from Day 1317 to 1457)

Number of participants with solicited local and systemic AEs for 7 days post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.

Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination
Up to 28 days post late boost vaccination (up to any day from Day 1317 to Day 1485) (late boost vaccination ranged from Day 1317 to 1457)

Number of participants with unsolicited AEs for 28 post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs)
From Week 188 up to end of study (Week 288)

Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study
From Week 188 up to end of study (Week 288)

Number of participants with AESIs up to the end of the study were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Confirmed HIV infection was considered an AESI.

Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS)
Up to 6 months post late boost vaccination (up to any day from Day 1317 to Day 1639) (late boost vaccination ranged from Day 1317 to 1457)

Number of participants with AESIs of TTS were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Thrombotic events and/or thrombocytopenia were considered as AESIs.

Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28
Week 28

Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.

Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52
Week 52

Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.

Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72
Week 72

Geometric mean of Env Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.

Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28
Week 28

Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.

Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52
Week 52

Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.

Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72
Week 72

Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192
Week 192

Geometric mean of Env Mos 1 specific binding Abs response at Week 192 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193
Week 193

Geometric Mean of Env Mos 1 specific binding Abs response at Week 193 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196
Week 196

Geometric mean of Env Mos 1 specific binding Abs response at Week 196 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204
Week 204

Geometric mean of Env Mos 1 specific binding Abs response at Week 204 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216
Week 216

Geometric mean of Env Mos 1 specific binding Abs response at Week 216 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240
Week 240

Geometric mean of Env Mos 1 specific binding Abs response at Week 240 were assessed using ELISA.

Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288
Week 288

Geometric mean of Env Mos 1 specific binding Abs response at Week 288 were assessed using ELISA.

Secondary Endpoints
Number of Participants With Solicited Local Adverse Events (AEs)
Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Number of Participants With Solicited Systemic Adverse Events (AEs)
Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Number of Participants With Unsolicited Adverse Events (AEs)
Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccineEXPERIMENTALParticipants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection).
Group 2: PlaceboPLACEBO_COMPARATORParticipants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Group 1: Ad26.Mos4.HIV + Clade C gp140EXPERIMENTALParticipants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12, followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminium phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140EXPERIMENTALParticipants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + combination of 125 mcg Mosaic gp140 and 125 mcg Clade C gp140 mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Group 3: PlaceboPLACEBO_COMPARATORParticipants will receive a single placebo injection at Weeks 0 and 12, followed by two placebo injections at Weeks 24 and 48.
Group 1b: Ad26.Mos4.HIV + gp140 HIV Bivalent VaccineEXPERIMENTALParticipants enrolled in the LTE phase will receive late boost vaccination Ad26.Mos4.HIV and bivalent gp140 within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, approximately 3 years after the 4th vaccination of the primary vaccination series).
Group 2b: PlaceboPLACEBO_COMPARATORParticipants will receive placebo injection at Week 192 -4 weeks/+4 months, that is, approximately 3 years after the 4th vaccination of the primary vaccination series.
Interventions
NameTypeDescription
Ad26.Mos4.HIVBIOLOGICALParticipants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.
Clade C and Mosaic gp140 HIV bivalent vaccineBIOLOGICALParticipants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.
PlaceboBIOLOGICALParticipants will receive matching placebo.
Clade C gp140 plus adjuvantBIOLOGICALClade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection administered intramuscularly.
Clade C gp140/Mosaic gp140 plus adjuvantBIOLOGICALClade C gp140 and Mosaic gp140 (each 125 mcg of total protein) mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection, administered intramuscularly.
gp140 HIV Bivalent VaccineBIOLOGICALgp140 HIV Bivalent Vaccine is adjuvanted protein co-formulation with a dosage strength of 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant).
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites53

Inclusion Criteria: * Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conform...

Countries:United StatesArgentinaBrazilItalyMexicoPeruPolandPuerto RicoSpainKenyaRwanda
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