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
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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
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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:
- 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
- Creatinine: > 1. 1 x ULN
- AST: >2.6 x ULN
- ALT: >2.6 x ULN
Urinalysis: abnormal dipstick confirmed by microscopy
- Protein 2+ or more
- Blood 2+ or more (not due to menses)
- History or evidence of autoimmune disease.
- Positive for Hepatitis B surface antigen (HbsAg), positive for antibodies to Hepatitis C virus (HCV) or active syphilis.
- Receipt of blood or blood products within the previous 6 months
- History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
- Prior or current participation in another investigational agent trial except to the EV06 trial
- Current anti-tuberculosis (TB) prophylaxis or therapy
- If female, currently pregnant (positive serum or urine pregnancy test), planning to get pregnant in the next 9 months or lactating
- History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the volunteer's safety or interfere with the evaluation of the safety or immunogenicity of the vaccine
Volunteers will be enrolled regardless of schistosomiasis infection status. Volunteers with high S. mansoni egg count of >2000 eggs per gram of stool at screening will be treated before vaccination. Volunteers with low S mansoni egg count of <2000 eggs per gram of stool at screening will be asked to forgo treatment until after completion of week 24 visit of the trial. Volunteers with other helminth infections at screening will also receive treatment before vaccination.
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|
|Responsible Party:||EuroVacc Foundation|
|Other Study ID Numbers:||
|First Posted:||January 5, 2018 Key Record Dates|
|Last Update Posted:||February 7, 2019|
|Last Verified:||December 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases