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Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults

ConditionHIV Prevention
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorWorcester HIV Vaccine

About this trial

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA prime and gp120 (A,B,C,A/E) protein HIV-1 vaccines boost (PDPHV) with either Alhydrogel or GLA-SE in healthy, HIV-uninfected adults.

Volunteers will receive either the PDPHV or the placebo (normal saline) by intramuscular injections. Some volunteers will receive Alhydrogel and others will receive GLA-SE as part of the protein boost.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age of 18 to 55 years

Access to a trial site and willingness to be followed for the planned duration of the study.

Ability and willingness to provide informed consent

Demonstrates an understanding of the study

Disqualifiers

Blood products received within 120 days before first vaccination.

Investigational research agents received within 30 days before first vaccination.

Body mass index (BMI) ≥ 40.

Intent to participate in another study of an investigational research agent or any other study that requires HIV antibody testing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))

    Biological/Vaccine

    The polyvalent DNA Vaccines contains equal amounts of 5 individual DNA plasmid components utilizing the same vector pSW3891. Four plasmids each containing a codon optimized gp120 gene sequence from HIV-1 subtype A, B, C and CRF01\_AE consensus, and a fifth plasmid containing a codon optimized gag gene from subtype C.

  • PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))

    Biological/Vaccine

    The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.

  • Alhydrogel adjuvant

    Biological/Vaccine

    PDPHV protein vaccines adjuvant

  • GLA-SE adjuvant

    Biological/Vaccine

    PDPHV protein vaccines adjuvant

  • Placebo for DNA Vaccines, Protein Vaccines and Adjuvants

    Biological/Vaccine

    Sodium Chloride for Injection, USP 0.9%.

Treatment groups

126 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Group 1 (Treatment): Protein Vaccines/AlhydrogelExperimental treatment 2 interventions
Group B: Group 1 (Control)Placebo comparator 1 intervention
Group C: Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boostExperimental treatment 3 interventions
Group D: Group 2 (Control)Placebo comparator 1 intervention
Group E: Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SEExperimental treatment 3 interventions
Group F: Group 3 (Control)Placebo comparator 1 intervention
Group G: Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boostExperimental treatment 3 interventions
Group H: Group 4 (Control)Placebo comparator 1 intervention
Group I: Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boostExperimental treatment 3 interventions
Group J: Group 5 (Control)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of local injection site (including DTH) reactogenicity signs and symptoms

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Time frame
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
2

Frequency of systemic reactogenicity signs and symptoms

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Time frame
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
3

Frequency of adverse events (AEs)

AEs categorized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class, MedDRA preferred term, severity, and assessed relationship to study products

Time frame
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
4

Severity of local injection site (including DTH) reactogenicity signs and symptoms

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Time frame
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in

Secondary outcomes

1

Serum neutralizing antibody responses against Tier 1A, Tier 1B, and selected Tier 2 viruses

Assessed by TZM-bl assay

Time frame
Measured at 2 weeks after the last vaccination at month 6.5
2

Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses

Assessed by intracellular cytokine staining (ICS)

Time frame
Measured at 2 weeks after the last vaccination at month 6.5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Worcester HIV Vaccine

Lead sponsor

Desmond Tutu Health Foundation

Collaborator

Brigham and Women's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: