Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial

NCT03391375 | Completed Phase 1 DMC

• 1 other identifier: EV07
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (5)

• Vaccine induced binding antibody responses

  HIV-specific Env binding Antibody response

  week 24

• Vaccine induced neutralizing antibody responses

  Neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates

  week 24

• Safety and tolerability of the late boost vaccination

  Proportion of volunteers with local and systemic reactogenicity events

  7 days follow-up period after the late boost

• Safety and tolerability of the late boost vaccination

  Proportion of volunteers with adverse events

  4-week follow-up period after the late boost

• Safety and tolerability of the late boost

  Proportion of volunteers with serious adverse events

  Up to 24 weeks

Secondary Outcomes (1)

• Ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced T-cell responses

  Week 2, 12 and 24

Study Arms (1)

DNA-Protein

EXPERIMENTAL

Co-administration of DNA-HIV-PT123 and AIDSVAX B/E at week 0, 4 and 24

Biological: DNA-HIV-PT123 & AIDSVAX B/E

Interventions

DNA-HIV-PT123 & AIDSVAX B/E BIOLOGICAL

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

DNA-Protein

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participated in the EV06 trial and received all three vaccinations from EV06 trial
• HIV uninfected adults, as confirmed by a medical history, physical exam, and laboratory tests during screening
• Able and willing to provide written informed consent prior to screening
• Aged at least 18 at the time of consent
• Able and willing to complete screening (about 1 month) and available for the planned follow-up period (6 months)
• Willing to undergo HIV testing, risk reduction counselling and receive HIV test results
• If female of childbearing potential (unless sterilised), willing to use a non-barrier contraceptive method from screening through the end of the study. Acceptable contraceptive methods include hormonal contraceptives (injection, transdermal patch, or implant) and intrauterine device (IUD).
• If male, willing to use male condoms and not make a woman pregnant from enrolment through the end of the study.
• Willing to provide blood, urine and stool samples for laboratory examination

You may not qualify if:

• HIV-1/2 infection
• Symptomatic and asymptomatic malaria infection (presence of malaria parasites on thick blood smear)
• Clinically significant acute or chronic illness at the time of randomization.
• Any clinically relevant abnormality on history or examination
• Use of immunosuppressive medication (other than inhaled or topical immunosuppressants)
• Receipt of immunoglobulin within past 60 days
• Abnormal laboratory values as specified below from blood collected within 42 days prior to randomization:
• Hematology
• Haemoglobin \<9.0 g/dL or \<5.59 mmol/L
• Absolute Neutrophil Count (ANC): \< 1000/mm3 or \< 1.0 x 109/L
• Absolute Lymphocyte Count (ALC): ≤ 500/mm3 or ≤ 0.5 x 109/L
• Platelets: ≤ 90,000 ≥ 550,000/mm3 or ≤ 90 x 109 ≥ 550 x 109/L
• Chemistry
• Creatinine: \> 1. 1 x ULN
• AST: \>2.6 x ULN

Sponsors & Collaborators

• EuroVacc Foundation: lead
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• International AIDS Vaccine Initiative: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

Uganda Virus Research Institute - International AIDS Vaccine Initiative HIV Vaccine Program (UVRI-IAVI)

Entebbe, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

AIDSVAX B-E

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Pontiano Kaleebu

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 5, 2018
• Study Start: March 15, 2017
• Primary Completion: January 1, 2018
• Study Completion: July 31, 2018
• Last Updated: February 7, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)