AIDSPhase 1/2HIV-CORE 004NCT02099994
Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults
A Phase 1/2 study testing Ad35-GRIN, MVA.HIVconsv and pSG2.HIVconsv DNA in people with AIDS, run by University of Oxford at 1 site in Kenya.
Trial summary
The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- AIDS
- What is being tested?
- Ad35-GRIN, MVA.HIVconsv and pSG2.HIVconsv DNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2014to Aug 2015
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-50
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- Written informed consent.
- Willing to undergo HIV-1 testing, counselling and receive test results.
- All female volunteers must be willing to undergo urine pregnancy tests
- If sexually active using an effective method of contraception until at least 4 months after the last vaccination.
- Willing to forgo donating blood during the study.
Who cannot join
- Any relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the Principal Investigator or designee, is clinically significant, within the previous 6 months. (Note: use of inhaled steroids for asthma or use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
- Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study.
- Any of the following abnormal laboratory parameters (1 abnormal test may be repeated once if thought to be due to a temporary condition):
- Haematology
- Haemoglobin < 9.0 g/dl for women and <11.0 g/dl for men
- Absolute Neutrophil Count (ANC) ≤ 1000 /mm3 (≤ 1 x 109 /l)
Show all 31Show fewer
- Absolute Lymphocyte Count (ALC) ≤ 600 /mm3 (≤0.6 x 109 /l)
- Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)
- Biochemistry
- Creatinine > 1.3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) > 2.5 x ULN
- Alanine aminotransferase (ALT) > 2.5 x ULN
- Urinalysis- Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 2+ or more
- Blood = 2+ or more (for women: before or after menses)
- Confirmed HIV-1 or HIV-2 infection.
- If female, pregnant or planning a pregnancy any time from enrolment to 4 months after the last vaccination; or lactating.
- Receipt of live attenuated vaccine within the previous 60 days or planned receipt at any time until 60 days after vaccination with Investigational Medicinal Product (IMP) or receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt at any time until 14 days after vaccination with the IMP.
- Receipt of blood transfusion or blood products within the previous 6 months.
- Participation in another clinical trial of an IMP currently or within the previous 3 months or expected participation during this study.
- Receipt of any investigational HIV-1 vaccine within the last 6 years.
- History of severe or very severe local or systemic reactogenicity events after vaccination, or history of severe or very severe allergic reactions.
- Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous clearance leading to natural immunity, indicated by antibodies to core + antigens, is not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection; untreated syphilis.
- Smallpox vaccination within the previous 3 years.
- Major psychiatric illness in the previous 3 years.
- History of allergy or hypersensitivity to latex, chronic skin problems such as eczema or psoriasis, or skin and subcutaneous tissue thickness > 40 mm as assessed by skin pinch test in either deltoid region.
- Presence of an implantable device
- Current use of any electronic stimulation device. Therapeutic or traumatic metal implant in either deltoid region.
- History of, or known active cardiac disease or a heart condition under the care of a doctor. Note: Slight physiological variation of normal resting heart rate (60 - 100 beats/minute) with respiration is NOT excluded.
- History of syncope or fainting episode within 1 year of study entry.
- Seizure disorder or any history of prior seizure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.
The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.
Read the detailed description
The main objectives of this study are to determine the vaccines' safety and immunogenicity in an African population, and further strengthen the vaccine trial capacity in the South.
HIV-CORE 004 is a double blind, placebo controlled randomized Phase I/IIa study designed to evaluate the safety and immunogenicity of different delivery regimens using three novel HIV-1 vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M) administered by intramuscular needle injection in heterologous prime-boost regimens.
72 healthy, low-risk, HIV-1-uninfected adult volunteers in Nairobi will be randomly assigned to one of three groups, AM, DDDAM and DeDeDeAM each containing 20 vaccinees and 4 placebo recipients.
Firstly, this study aims to evaluate the safety and tolerability of the vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M).
Secondly, we shall determine the effect of electroporation during DNA priming on the frequency, durability and/or quality of T cell responses (DDDAM vs DeDeDeAM).
Thirdly, we shall determine whether priming with three DNA vaccinations with or without electroporation affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen compared to that seen in the AM regimen (AM vs DDDAM/DeDeDeAM).
As this is the first study of the combined HIVconsv vaccines in an African population, of the pSG2.HIVconsv DNA with electroporation, and the combination of the two HIVconsv vaccines with Ad35-GRIN, this trial has been designed as a pilot study to compare different vector combinations. The sample sizes will only allow detection of large response differences between volunteers in the three groups, thus, yielding data that are primarily descriptive.
- Conditions
- AIDS
- Being tested
- Ad35-GRIN, MVA.HIVconsv, pSG2.HIVconsv DNA, Electroporated pSG2.HIVconsv
- Keywords
- HIV, vaccine
- 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.
Ad35-GRINBiological
intramuscular administration of Ad35-GRIN 5 x 10^10 vp or saline placebo
MVA.HIVconsvBiological
IM administration of MVA.HIVconsv 2 x 10^8 pfu or saline placebo
pSG2.HIVconsv DNABiological
IM administration of pSG2.HIVconsv DNA 4 mg or saline placebo
Electroporated pSG2.HIVconsvBiological
IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo
| Study group | Role | What they receive |
|---|---|---|
| A - AM | Experimental | Ad35-GRIN 5 x 10^10 vp IM at week 0, MVA.HIVconsv 2 x 10^8 pfu IM at week 8. Receives: Biological: Ad35-GRIN; Biological: MVA.HIVconsv |
| B - DDDAM | Experimental | pSG2.HIVconsv DNA 4 mg or saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo at week 20. Receives: Biological: Ad35-GRIN; Biological: MVA.HIVconsv; Biological: pSG2.HIVconsv DNA |
| C - DeDeDeAM | Experimental | Electroporated pSG2.HIVconsv 4 mg or electroporated saline placebo at weeks 0, 4 and 8.
Ad35-GRIN 5 x 10^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo at week 20. Receives: Biological: Ad35-GRIN; Biological: MVA.HIVconsv; Biological: Electroporated pSG2.HIVconsv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Safety
Proportion of volunteers who develop a grade 3 or 4 local reaction. Proportion of volunteers who develop a grade 3 or 4 systemic reaction
Measured: 44 weeks
Secondary outcomes (2)
Vaccine immunogenicity
T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay
Measured: 44 weeks
Vaccine Safety
A descriptive summary of grade 3 of 4 local and systemic events including laboratory abnormalities.
A descriptive summary of serious adverse events, including laboratory abnormalities
Measured: 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), International AIDS Vaccine Initiative, Karolinska Institutet, University of Nairobi, Ichor Medical Systems Incorporated
- Responsible party
- Sponsor
- Investigators
- Walter Jaoko, Principal investigator, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099994
- Sponsor's protocol ID
- HIV-CORE 004/IAVI N004
- Acronym
- HIV-CORE 004
- Status last verified
- May 2016
- First submitted
- 26 Mar 2014
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.
- ClinicalTrials.gov ID
- NCT02099994
- Acronym / sponsor ID
- HIV-CORE 004 / HIV-CORE 004/IAVI N004
- Conditions
- AIDS
- Keywords
- HIV, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), International AIDS Vaccine Initiative, Karolinska Institutet, University of Nairobi, Ichor Medical Systems Incorporated
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Mar 2014 (estimated)
- 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.
The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.
Detailed description
The main objectives of this study are to determine the vaccines' safety and immunogenicity in an African population, and further strengthen the vaccine trial capacity in the South.
HIV-CORE 004 is a double blind, placebo controlled randomized Phase I/IIa study designed to evaluate the safety and immunogenicity of different delivery regimens using three novel HIV-1 vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M) administered by intramuscular needle injection in heterologous prime-boost regimens.
72 healthy, low-risk, HIV-1-uninfected adult volunteers in Nairobi will be randomly assigned to one of three groups, AM, DDDAM and DeDeDeAM each containing 20 vaccinees and 4 placebo recipients.
Firstly, this study aims to evaluate the safety and tolerability of the vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M).
Secondly, we shall determine the effect of electroporation during DNA priming on the frequency, durability and/or quality of T cell responses (DDDAM vs DeDeDeAM).
Thirdly, we shall determine whether priming with three DNA vaccinations with or without electroporation affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen compared to that seen in the AM regimen (AM vs DDDAM/DeDeDeAM).
As this is the first study of the combined HIVconsv vaccines in an African population, of the pSG2.HIVconsv DNA with electroporation, and the combination of the two HIVconsv vaccines with Ad35-GRIN, this trial has been designed as a pilot study to compare different vector combinations. The sample sizes will only allow detection of large response differences between volunteers in the three groups, thus, yielding data that are primarily descriptive.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - AM | Experimental | Biological: Ad35-GRIN, Biological: MVA.HIVconsvAd35-GRIN 5 x 10^10 vp IM at week 0, MVA.HIVconsv 2 x 10^8 pfu IM at week 8. |
| B - DDDAM | Experimental | Biological: Ad35-GRIN, Biological: MVA.HIVconsv, Biological: pSG2.HIVconsv DNApSG2.HIVconsv DNA 4 mg or saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo at week 20. |
| C - DeDeDeAM | Experimental | Biological: Ad35-GRIN, Biological: MVA.HIVconsv, Biological: Electroporated pSG2.HIVconsvElectroporated pSG2.HIVconsv 4 mg or electroporated saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo at week 20. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18-50
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- Written informed consent.
- Willing to undergo HIV-1 testing, counselling and receive test results.
- All female volunteers must be willing to undergo urine pregnancy tests
Key exclusion criteria (31 listed)
- Any relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the Principal Investigator or designee, is clinically significant, within the previous 6 months. (Note: use of inhaled steroids for asthma or use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
- Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study.
- Any of the following abnormal laboratory parameters (1 abnormal test may be repeated once if thought to be due to a temporary condition):
- Confirmed HIV-1 or HIV-2 infection.
- If female, pregnant or planning a pregnancy any time from enrolment to 4 months after the last vaccination; or lactating.
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 |
|---|---|---|
| Ad35-GRINintramuscular administration of Ad35-GRIN 5 x 10^10 vp or saline placebo | Biological | A - AM, B - DDDAM, C - DeDeDeAM |
| MVA.HIVconsvIM administration of MVA.HIVconsv 2 x 10^8 pfu or saline placebo | Biological | A - AM, B - DDDAM, C - DeDeDeAM |
| pSG2.HIVconsv DNAIM administration of pSG2.HIVconsv DNA 4 mg or saline placebo | Biological | B - DDDAM |
| Electroporated pSG2.HIVconsvIM administration of electroporated pSG2.HIVconsv 4mg or saline placebo | Biological | C - DeDeDeAM |
Primary outcome
Vaccine Safety
Time frame: 44 weeks
Proportion of volunteers who develop a grade 3 or 4 local reaction. Proportion of volunteers who develop a grade 3 or 4 systemic reaction
2 secondary outcomes
Vaccine immunogenicity
Time frame: 44 weeks
Vaccine Safety
Time frame: 44 weeks
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 30 May 2016.
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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.
Walter Jaoko principal investigator
University of Nairobi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad35-GRIN, MVA.HIVconsv and pSG2.HIVconsv DNA in people with AIDS, run by University of Oxford at 1 site in Kenya.
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 7 inclusion and 31 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 30 May 2016. 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 Kenya. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Safety (time frame: 44 weeks). 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 30 May 2016.