NCT03408262

Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women

A Phase I Single-Blind Randomised Trial Investigating Immunisation Strategies Using Ad4-EnvCN54, MVA-CN54 and CN54gp140/MPLA Combinations in Order to Maximise Antibody Responses to Human Immunodeficiency Virus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase I Single-Blind randomised trial investigating immunisation strategies using Ad4-EnvCN54, MVA-CN54 and CN54gp140/MPLA combinations in order to maximise antibody responses to Human Immunodeficiency Virus

Detailed description

This is a randomised two-part Phase I study which will explore the impact of different boosting options (MVA-CN54 and recombinant CN54gp140 protein) for oral Adenovirus serotype 4 vector prime expressing HIV-1 CN54 envelope (Ad4-EnvCN54) designed to optimize systemic and mucosal antibody responses. Part 1 is exploratory and designed to select conditions capable of promoting enhanced systemic and mucosal B cell responses in a limited number of participants. Part 2 is dependent upon Part 1 and is designed to study groups selected on performance in part 1 in an expanded number of subjects. Data from both stages will be combined for safety and immunological analyses.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
BIOLOGICAL	Ad4-EnvCN54	Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
BIOLOGICAL	MVA-CN54	Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
BIOLOGICAL	CN54gp140/MPLA	Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant

Timeline

• Start date: 2017-10-06
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2018-01-23
• Last updated: 2024-10-16
• Results posted: 2024-10-16

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study