Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial
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|ClinicalTrials.gov Identifier: NCT03391375|
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : February 7, 2019
EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial.
The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1.
Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses.
The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Biological: DNA-HIV-PT123 & AIDSVAX B/E||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||July 31, 2018|
Co-administration of DNA-HIV-PT123 and AIDSVAX B/E at week 0, 4 and 24
Biological: DNA-HIV-PT123 & AIDSVAX B/E
DNA-HIV-PT123 encodes clade C ZM96 Gag and gp140, CN54 Pol-Nef; AIDSVAX®B/E is a subtype B (MN) and subtype E (A244) HIV gp120 glycoprotein adsorbed onto aluminium hydroxide gel adjuvant
- Vaccine induced binding antibody responses [ Time Frame: week 24 ]HIV-specific Env binding Antibody response
- Vaccine induced neutralizing antibody responses [ Time Frame: week 24 ]Neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates
- Safety and tolerability of the late boost vaccination [ Time Frame: 7 days follow-up period after the late boost ]Proportion of volunteers with local and systemic reactogenicity events
- Safety and tolerability of the late boost vaccination [ Time Frame: 4-week follow-up period after the late boost ]Proportion of volunteers with adverse events
- Safety and tolerability of the late boost [ Time Frame: Up to 24 weeks ]Proportion of volunteers with serious adverse events
- Ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced T-cell responses [ Time Frame: Week 2, 12 and 24 ]HIV-specific CD4 and CD8 T cell responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391375
|Uganda Virus Research Institute - International AIDS Vaccine Initiative HIV Vaccine Program (UVRI-IAVI)|
|Principal Investigator:||Pontiano Kaleebu||MRC/UVRI and LSHTM Uganda Research Unit|