Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALVAC-HIV vCP1521+ AIDSVAX · 1 trial · 1 indication
HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
| Arm | Type | Description |
|---|---|---|
| Vaccine | ACTIVE_COMPARATOR | ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. |
| Placebo | PLACEBO_COMPARATOR | ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. |
| Name | Type | Description |
|---|---|---|
| ALVAC-HIV vCP1521 + AIDSVAX | BIOLOGICAL | Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL |
| ALVAC Placebo + AIDSVAX Placebo | OTHER | ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection |
Inclusion Criteria: * Possession of the 13-digit Thai National ID card * 18-30 years of age (inclusive), male or female * For women, a negative urine pregnancy test on the day of enrollment, as well as assurance that adequate birth control measures would be applied during the course of the injectio...
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ALVAC-HIV vCP1521+ AIDSVAX is an investigational vaccine combination studied for the prevention of HIV infection. It was evaluated in a Phase 3 clinical trial in Thai adults. The combination is designed to elicit an immune response against HIV, though it is not approved and remains in clinical development.
ALVAC-HIV vCP1521+ AIDSVAX is developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is conducting clinical research on this vaccine combination for HIV infection. The development program includes a completed Phase 3 trial.
ALVAC-HIV vCP1521+ AIDSVAX is in Phase 3 clinical development. The Phase 3 trial, NCT00223080, has been completed. The vaccine combination is investigational and has not been approved for use. It was studied in a large trial with over 16,000 participants.
ALVAC-HIV vCP1521+ AIDSVAX has one completed Phase 3 clinical trial, NCT00223080, titled 'HIV Vaccine Trial in Thai Adults.' This randomized, double-blind, placebo-controlled trial enrolled 16,402 participants in Thailand. The study included healthy volunteers aged 18 years and older.
ALVAC-HIV vCP1521+ AIDSVAX is a combination regimen that includes AIDSVAX as one component. The full regimen combines the ALVAC-HIV vCP1521 vector with the AIDSVAX protein subunit vaccine. This combination was tested together in the Phase 3 trial for HIV prevention.