# A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

> **NCT04066881** · PHASE2 · COMPLETED · sponsor: **MRC/UVRI and LSHTM Uganda Research Unit** · enrollment: 1512 (actual)

## Conditions studied

- HIV Infections

## Interventions

- **BIOLOGICAL:** Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)
- **BIOLOGICAL:** Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48)
- **BIOLOGICAL:** Vaccine Group C: Saline placebo (weeks 0,4,24,48)
- **DRUG:** Control PrEP:TDF/FTC once daily (weeks 0-26)
- **DRUG:** Experimental PrEP:TAF/FTC once daily (weeks 0-26)

## Key facts

- **NCT ID:** NCT04066881
- **Lead sponsor:** MRC/UVRI and LSHTM Uganda Research Unit
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-12-15
- **Primary completion:** 2024-12-31
- **Final completion:** 2024-12-31
- **Target enrollment:** 1512 (ACTUAL)
- **Last updated:** 2025-01-22

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04066881

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04066881, "A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT04066881. Licensed CC0.

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