Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02099994
Other study ID # HIV-CORE 004/IAVI N004
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 26, 2014
Last updated May 27, 2016
Start date March 2014
Est. completion date August 2015

Study information

Verified date May 2016
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority Kenya: Pharmacy and Poisons Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Ad35-GRIN
intramuscular administration of Ad35-GRIN 5 x 10^10 vp or saline placebo
MVA.HIVconsv
IM administration of MVA.HIVconsv 2 x 10^8 pfu or saline placebo
pSG2.HIVconsv DNA
IM administration of pSG2.HIVconsv DNA 4 mg or saline placebo
Electroporated pSG2.HIVconsv
IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo

Locations

Country Name City State
Kenya KAVI-Kangemi clinic Nairobi

Sponsors (6)

Lead Sponsor Collaborator
University of Oxford European and Developing Countries Clinical Trials Partnership (EDCTP), Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative, Karolinska Institutet, University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 44 weeks Yes
Secondary Vaccine immunogenicity T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay 44 weeks No
Secondary 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
44 weeks Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Not yet recruiting NCT03661203 - Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT01053598 - Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting N/A
Completed NCT01348308 - Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients Phase 3
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Withdrawn NCT00951795 - Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts N/A
Completed NCT00740389 - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects. Phase 1
Withdrawn NCT00347750 - Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations Phase 3
Completed NCT00317460 - Buprenorphine and Integrated HIV Care Phase 4
Withdrawn NCT00340223 - HLA-B35 Alleles and AIDS N/A
Completed NCT01084395 - Reducing HIV Risk Among Mexican Youth N/A
Completed NCT00144352 - In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults Phase 4
Completed NCT00202241 - The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS N/A
Completed NCT00341172 - The Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis
Recruiting NCT06145841 - Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies
Completed NCT03633721 - Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women Phase 2
Completed NCT04567693 - Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV N/A
Completed NCT03023033 - Supporting Attendance for Facility Delivery and Infant Health N/A