NCT02296541

A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of 3 Different HIV-1 DNA Priming Regimens (Nat-B Env, CON-S Env, and Mosaic Env) With MVA-CMDR Boosts in Healthy, HIV-1-Uninfected Adults

Completed Phase 1 Last updated 20 April 2023

What this trial tests

Phase 1 trial testing DNA Nat-B env in HIV Infections in 105 participants. Completed in 6 July 2020.

Timeline

1 December 2014

Primary endpoint
1 November 2016

6 July 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	105
Start date	1 December 2014
Primary completion	1 November 2016
Estimated completion	6 July 2020
Sites	7 locations across United States, Switzerland

Drugs / interventions tested

• DNA Nat-B env — full drug profile →
• DNA CON-S env — full drug profile →
• DNA Mosaic env
• MVA-CMDR
• Placebo for DNA Nat-B env — full drug profile →
• Placebo for DNA CON-S env — full drug profile →
• Placebo for DNA Mosaic env
• Placebo for MVA-CMDR — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with HIV Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Frequency of local and systemic injection site reactogenicity signs and symptoms for each type of vaccine
  Time frame: Measured through Month 8
• Severity of local and systemic injection site reactogenicity signs and symptoms for each type of vaccine
  Time frame: Measured through Month 8
• Frequency of adverse events (AEs)
  Time frame: Measured through participant follow-up (3 and 5 years for participants in the United States and Switzerland, respectively)
  Categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products; detailed description of all AEs meeting Division of AIDS (DAIDS) criteria for expedited reporting (EAE)
• Laboratory measure of safety: measurement of white blood cells (WBC)
  Time frame: Measured through Month 8
• Laboratory measure of safety: measurement of neutrophils
  Time frame: Measured through Month 8
• Laboratory measure of safety: measurement of lymphocytes
  Time frame: Measured through Month 8

Sponsor's own description

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress in HIV vaccine development.
   Hsu DC, O'Connell RJ. · · 2017 · cited 62× · PMID 28281871 · DOI 10.1080/21645515.2016.1276138
2. Current views on the potential for development of a HIV vaccine.
   Cohen KW, Frahm N. · · 2017 · cited 22× · PMID 28095712 · DOI 10.1080/14712598.2017.1282457
3. Conformational flexibility of HIV-1 envelope glycoproteins modulates transmitted/founder sensitivity to broadly neutralizing antibodies.
   Parthasarathy D, Pothula KR, Ratnapriya S, Cervera Benet H, et al · · 2024 · cited 17× · PMID 39187497 · DOI 10.1038/s41467-024-51656-4
4. Enhancing anti-viral neutralization response to immunization with HIV-1 envelope glycoprotein immunogens.
   Ahmed S, Parthasarathy D, Newhall R, Picard T, et al · · 2023 · cited 14× · PMID 37996435 · DOI 10.1038/s41541-023-00774-z
5. The potential and challenges of circular RNA in the development of vaccines and drugs for emerging infectious diseases.
   Chen K, Xu Y, Li J, Gu S, et al · · 2025 · cited 10× · PMID 40951762 · DOI 10.1016/j.omtn.2025.102687
6. Trivalent mosaic or consensus HIV immunogens prime humoral and broader cellular immune responses in adults.
   Cohen KW, Fiore-Gartland A, Walsh SR, Yusim K, et al · · 2023 · cited 10× · PMID 36787249 · DOI 10.1172/jci163338
7. New developments in an old strategy: heterologous vector primes and envelope protein boosts in HIV vaccine design.
   Musich T, Robert-Guroff M. · · 2016 · cited 10× · PMID 26910195 · DOI 10.1586/14760584.2016.1158108
8. Immunogenicity of NYVAC Prime-Protein Boost Human Immunodeficiency Virus Type 1 Envelope Vaccination and Simian-Human Immunodeficiency Virus Challenge of Nonhuman Primates.
   Saunders KO, Santra S, Parks R, Yates NL, et al · · 2018 · cited 9× · PMID 29437967 · DOI 10.1128/jvi.02035-17