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BG505 SOSIP.664 gp140, adjuvanted

Phase 1

HIV Infections | Monoclonal antibody | Infectious Disease |GSK plc|Trials Updated: Dec 14, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

BG505 SOSIP.664 gp140, adjuvanted clinical trials

BG505 SOSIP.664 gp140, adjuvanted · 1 trial · 1 indication

Phase 1 1
NCT03699241A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected AdultsHIV Infections
COMPLETED61 Analytics
PHASE1COMPLETED
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults
HIV Infections
NCT0369924161
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Study Endpoints

Primary Endpoints

Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination
7 days post-vaccination

To evaluate the safety and tolerability of the study regimens based on the frequency of local and systemic reactogenicity events as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination
28 days post-vaccination

To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with moderate or greater unsolicited adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period
18 months

To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with vaccine-related serious adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

Proportion of volunteers in each group with potential immune-mediated diseases (pIMD) from the day of injection throughout the study period
18 months

To evaluate the proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) based on a defined list of pIMDs in the study protocol.

Secondary Endpoints

To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:
20 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1PLACEBO_COMPARATORHIV-Uninfected participants
Group 2PLACEBO_COMPARATORHIV-Uninfected participants
Group 3PLACEBO_COMPARATORHIV-Uninfected participants
Group 4PLACEBO_COMPARATORHIV-Uninfected participants
Group 5PLACEBO_COMPARATORHIV-Uninfected participants

Interventions

NameTypeDescription
BG505 SOSIP.664 gp140, adjuvantedBIOLOGICALDosage of 30ug, Intramuscular administration
PlaceboBIOLOGICALTris-NaCl Diluent
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests 2. At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination 3. Willing to comply...

Countries:United StatesKenya
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Competitive Landscape -Bacterial Infections 80 trials (matched to "HIV Infections")

Top 19 of 29 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE7PHASE3VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4
Sanofi SA Sponsored ADRSNY1PHASE3PCV21
GSK plc Sponsored ADRGSK4PHASE2Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD1PHASE3DefenCath
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS2PHASE2EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline, Sulbactam-durlobactam
BiomX Inc.PHGE1PHASE2BX004
Hoffmann-La RocheRHHBY1PHASE3Baloxavir Marboxil
Merck & Co., Inc.MRK2PHASE1V118C
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV/kg
Phathom Pharmaceuticals, Inc.PHAT1 - Vonoprazan
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