A Study to Test Three Experimental HIV Vaccines in Healthy Adults.

Summary

HIV-CORE 006 is a Phase 1 double-blind placebo-controlled trial, in which the mosaic immunogens are delivered by a prime-boost regimen of non-replicating simian adenovirus followed by non-replicating poxvirus MVA. Volunteers will be randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously. The trial will recruit healthy African adults 18-50 years of age, who are HIV-uninfected and at low risk of HIV infection.

The trial is designed to enrol 88 healthy men and women, who will be randomised to receive either the vaccine regimen or placebo in a ratio of 72:16:

* Vaccine Arm (ChAdOx1.tHIVconsv1 prime followed by MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at 4 weeks after enrolment); 72 vaccine recipients;
* Placebo Arm; 16 recipients

To maintain blinding, all volunteers will receive two injections with half dose into the deltoid region of each arm of ChAdOx1.tHIVconsv1 or placebo at enrolment, and two injections (MVA.tHIVconsv3 or placebo into one deltoid region and MVA.tHIVconsv4 or placebo into the other) at 4 weeks after enrolment. The primary goal of assessing safety and immunogenicity will be served by weighting the randomisation toward vaccinees.

Conditions

• HIV-1-infection

Interventions

BIOLOGICAL

Vaccine

IM vaccination with ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVconsv4

BIOLOGICAL

Placebo

IM administration of 0.9% sterile sodium chloride solution

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• University of Nairobi

  collaborator OTHER

• KEMRI-Wellcome Trust Collaborative Research Program

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• International AIDS Vaccine Initiative

  collaborator NETWORK

• Imperial College London

  collaborator OTHER

• Center for Family Health Research in Zambia

  collaborator UNKNOWN

• University of Oxford

  lead OTHER

Principal Investigators

• Walter Jaoko, MD · University of Nairobi

• Pontiano Kaleebu, MD · London School of Hygiene and Tropical Medicine

• William Kilembe, MD · Center for Family Health Research in Zambia

• Eduard Sanders, MD · KEMRI-Wellcome Trust

• Paola Cicconi, MD · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-08-16

Primary Completion

2022-11-30

Completion

2022-11-30

Countries

• Kenya
• Uganda
• Zambia

Study Locations