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ALVAC-HIV
ALVAC-HIV is a vaccine Biologic drug developed by U.S. Army Medical Research and Development Command. It is currently in Phase 2 development for Prevention of HIV infection. Also known as: (vCP1521), vCP1521.
ALVAC-HIV is a recombinant canarypox virus vaccine that expresses HIV-1 proteins to stimulate an immune response against HIV.
ALVAC-HIV is a recombinant canarypox virus vaccine that expresses HIV-1 proteins to stimulate an immune response against HIV. Used for Prevention of HIV infection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ALVAC-HIV |
|---|---|
| Also known as | (vCP1521), vCP1521 |
| Sponsor | U.S. Army Medical Research and Development Command |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
The vaccine works by introducing HIV-1 proteins to the body, which triggers an immune response and helps the body recognize and attack HIV-infected cells. This can potentially prevent or reduce the severity of HIV infection.
Approved indications
- Prevention of HIV infection
Common side effects
- Injection site reactions
- Fever
- Headache
Key clinical trials
- RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV (PHASE1)
- HIV Vaccine in HIV-uninfected Adults (PHASE1)
- A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP (PHASE2)
- Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine (PHASE1, PHASE2)
- Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa (PHASE2, PHASE3)
- Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission (PHASE1)
- Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults (PHASE1)
- Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALVAC-HIV CI brief — competitive landscape report
- ALVAC-HIV updates RSS · CI watch RSS
- U.S. Army Medical Research and Development Command portfolio CI
Frequently asked questions about ALVAC-HIV
What is ALVAC-HIV?
How does ALVAC-HIV work?
What is ALVAC-HIV used for?
Who makes ALVAC-HIV?
Is ALVAC-HIV also known as anything else?
What drug class is ALVAC-HIV in?
What development phase is ALVAC-HIV in?
What are the side effects of ALVAC-HIV?
Related
- Drug class: All vaccine drugs
- Manufacturer: U.S. Army Medical Research and Development Command — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of HIV infection
- Also known as: (vCP1521), vCP1521
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing