HIV/AIDSPhase 1NCT03391375
Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial
A Phase 1 study testing DNA-HIV-PT123 & AIDSVAX B/E in people with HIV/AIDS, run by EuroVacc Foundation at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- DNA-HIV-PT123 & AIDSVAX B/E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUganda
- Study dates
- 15 Mar 2017to 31 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Uganda Virus Research Institute - International AIDS Vaccine Initiative HIV Vaccine Program (UVRI-IAVI)
Entebbe
About this study
Official title: An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial
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.
Read more
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
- Being tested
- DNA-HIV-PT123 & AIDSVAX B/E
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA-HIV-PT123 & AIDSVAX B/EBiological
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
| Study group | Role | What they receive |
|---|---|---|
| DNA-Protein | Experimental | Co-administration of DNA-HIV-PT123 and AIDSVAX B/E at week 0, 4 and 24 Receives: Biological: DNA-HIV-PT123 & AIDSVAX B/E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine induced binding antibody responses
HIV-specific Env binding Antibody response
Measured: week 24
Vaccine induced neutralizing antibody responses
Neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates
Measured: week 24
Safety and tolerability of the late boost vaccination
Proportion of volunteers with local and systemic reactogenicity events
Measured: 7 days follow-up period after the late boost
Safety and tolerability of the late boost vaccination
Proportion of volunteers with adverse events
Measured: 4-week follow-up period after the late boost
Safety and tolerability of the late boost
Proportion of volunteers with serious adverse events
Measured: 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
HIV-specific CD4 and CD8 T cell responses
Measured: Week 2, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start15 Mar 2017
- Primary completion1 Jan 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroVacc Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit, International AIDS Vaccine Initiative, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Pontiano Kaleebu, Principal investigator, MRC/UVRI and LSHTM Uganda Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391375
- Sponsor's protocol ID
- EV07
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial
- ClinicalTrials.gov ID
- NCT03391375
- Acronym / sponsor ID
- EV07
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- EuroVacc FoundationUniversity, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit, International AIDS Vaccine Initiative, Centre Hospitalier Universitaire Vaudois
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DNA-Protein | Experimental | Biological: DNA-HIV-PT123 & AIDSVAX B/ECo-administration of DNA-HIV-PT123 and AIDSVAX B/E at week 0, 4 and 24 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA-HIV-PT123 & AIDSVAX B/EDNA-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 | Biological | DNA-Protein |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pontiano Kaleebu principal investigator
MRC/UVRI and LSHTM Uganda Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA-HIV-PT123 & AIDSVAX B/E in people with HIV/AIDS, run by EuroVacc Foundation at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine induced binding antibody responses (time frame: week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.