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Attenuvax

Phase 2

HIV Infections | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 28, 2021

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00000815A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials GroupPHASE2 COMPLETED 270 -Aug 1, 2001Oct 28, 202146 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age
Throughout study
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.
Throughout study
Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age
Throughout study
Secondary Endpoints
Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age
Throughout study
Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees
Throughout study
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees
Throughout study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALParticipants who receive vaccination at 6 and 12 months of age
2EXPERIMENTALParticipants who receive vaccination only at 12 months of age
Interventions
NameTypeDescription
AttenuvaxBIOLOGICALMeasles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
M-M-R-IIBIOLOGICALMeasles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
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Eligibility Criteria
Age Range6 Months — 7 Months
SexALL
Healthy VolunteersYes
Study Sites46

Inclusion Criteria Patients must have: * Willing to have and receive results of HIV test * Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria. * No history of opportunistic infection. * No known exposure to measles within 14 days prior to study entry. * C...

Countries:United StatesPuerto Rico
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