Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT02099994
• Date of registration: 26/03/2014
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults HIV-CORE 004
• Scientific 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.
• Date of first enrolment: March 2014
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02099994
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 1/Phase 2

Countries of recruitment

Kenya

Contacts

• Name: Walter Jaoko
• Affiliation: University of Nairobi

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)

- 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

AIDS

Intervention(s)

Biological: Ad35-GRIN

Biological: MVA.HIVconsv

Biological: Electroporated pSG2.HIVconsv

Biological: pSG2.HIVconsv DNA

Primary Outcome(s)

Vaccine Safety [Time Frame: 44 weeks]

Secondary Outcome(s)

Vaccine immunogenicity [Time Frame: 44 weeks]

Vaccine Safety [Time Frame: 44 weeks]

Secondary ID(s)

HIV-CORE 004/IAVI N004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International AIDS Vaccine Initiative

Ichor Medical Systems Incorporated

European and Developing Countries Clinical Trials Partnership (EDCTP)

Karolinska Institutet

University of Nairobi