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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201304000534302 Date registered: 2013/04/24
TRIAL DESCRIPTION
Public title A Phase I Study of Prime-Boost HIV Vaccine Combinations
Official scientific title A Phase I Study of Prime-Boost HIV Vaccine Combinations Using Modified Vaccinia Ankara and Adenovirus Type 26 Vectors with Mosaic and Natural Sequence Inserts in Healthy, HIV-Uninfected Adults
Brief summary describing the background
and objectives of the trial
This is a randomized, placebo-controlled, double-blind clinical trial comparing prime-boost homologous regimens of MVA-vectors with mosaic versus natural sequence inserts & comparing heterologous regimens of Ad26 expressing modified gp140 HIV-1 clade An Env glycoprotein prime with either MVA-Mosaic versus MVA-Natural sequence boost. This study proposes to evaluate mosaic inserts versus natural sequence inserts in MVA-vectored vaccines in order to compare safety & immunogenicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2013-07-01
Actual trial start date
Anticipated date of last follow up 2015-04-30
Actual date of last follow up
Anticipated target sample size (number of participants) 120   
Actual target sample size (number of participants)   
Recruitment status Terminated
Secondary Ids Issuing authority/Trial register Links to Secondary ID
Protocol No. HIV-V-A001/RV307/IPCAVD005 Sponsor

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple Randomization using software program Allocation will be determined by the sponsor (statistician) who is situated off site. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Study Group 5 4 doses (0 months/3 months/6 months/12 months) In total: 12 months 4 placebo doses 20 Placebo
Experimental group Study Group 1 4 doses (0 months/3 months/6 months/12 months) In total: 12 months 4 doses of MVA-Mosaic 25
Experimental group Study Group 2 4 doses (0 months/3 months/6 months/12 months) In total: 12 months 4 doses of MVA-Natural 25
Experimental group Study Group 3 4 doses (0 months/3 months/6 months/12 months) In total: 12 months 2 doses of Ad26.ENVA.01 and 2 doses of MVA-Mosaic 25
Experimental group Study Group 4 4 doses (0 months/3 months/6 months/12 months) In total: 12 months 2 doses of Ad26.ENVA.01 and 2 doses of MVA-Natural 25

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Able to read and willing to complete the informed consent process. 2. ¿ 18 to 50 years old at the time of study enrollment (enrollment is defined as the time of first vaccination, but a participant must be 18 at time of consent). 3. Healthy adults (determined by medical history, physical examination, and clinical judgement). 4. Laboratory criteria within 56 days prior to enrollment: o Hemoglobin: Women: ¿11 g/dL; ¿Men 12.5 g/dL o White cell count: 2,500 to 11,000 cells/mm3 o Platelets: 125,000 to 450,000 per mm3 o Urinalysis: protein and blood <1+, glucose negative o ALT/AST¿1.25x institutional upper limits of normal, and creatinine ¿1.25x institutional upper limits of normal. 5. Negative for HIV infection (negative U.S. FDA-approved HIV diagnostic blood test). 6. All female subjects must: o Have a negative pregnancy test at the screening visit; o Have a negative pregnancy test immediately prior to each vaccine/placebo vaccination; o Provide verbal assurance that adequate birth control measures have been followed for 56 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3 months after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: ¿ Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin; ¿ Surgical methods (hysterectomy or bilateral tubal ligation); ¿ Condoms, diaphragms; ¿ Intrauterine device (IUD) or ¿ Abstinence. 7. Available and willing to participate for the duration of the study visits and follow up. 8. Amenable to HIV risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. 9. Pass the Test of Understanding. 10. Must be willing to provide verifiable identification. 11. Must have a means to be contacted. 12. Assessed by the clinic staff as being at low risk for HIV infection. 1. Confirmed HIV-1/-2 infection. 2. Chronic active hepatitis B or active hepatitis C or active syphilis infection. 3. A woman who is breastfeeding. 4. Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation. 5. Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study. 6. History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia. 7. ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis. 8. History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.) 9. Thyroidectomy, or thyroid disease requiring medication during the last 12 months. 10. Hypertension. 11. Major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation. 12. Receipt of live attenuated vaccine within 30 days or plans to receive within 30 days postvaccination. 13. Use of experimental therapeutic agents within 30 days of study entry. 14. Current or planned participation in another clinical study during the study period. 15. Receipt of blood products or immunoglobulin in the past 3 months 16. History of anaphylaxis or other serious adverse reactions to vaccines or egg products or neomycin or streptomycin 17. History of chronic urticaria 18. Chronic or recurrent use of medications which modify host immune response, e.g. cancer chemotherapeutic agents, parenteral corticosteroids 19. Recipient of an HIV vaccine candidate at any time, receipt of a pox-virus vaccine in the last 10 years, and receipt of other experimental vaccine(s) within the last 5 years. 20. Subjects who cannot communicate reliably with the investigator. 18 Years 50 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
No 2013/03/13 Makerere University Institute of Public Health IRB, OHRP IRB# 00005876; New Mulago Hospital Complex
Ethics Committee Address
Street address City Postal code Country
Upper Mulago Hill Road Kampala P.O. Box 7072 Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess safety and tolerability of each prime-boost regimen and Compare epitope mapping of homologous prime-boost regimens with MVA-vectors and either mosaic versus natural sequence inserts. after each cohort but also onb an ongoing basis

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University-Walter Reed Project (MUWRP) Plot 42, Nakasero Road Kampala PO 16524 Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
Crucell Holland BV Turnhoutseweg 30 Beerse 2340 Belgium
Military HIV Research Program (MHRP) 6720A Rockledge Drive Bethesda MD United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Turnhoutseweg 30 Beerse 2340 Belgium Company
Secondary Sponsor U.S. Military HIV Research Program (MHRP) 6720-A Rockledge Drive, Suite 400 Bethesda MD 20817 United States of America Foundation

COLLABORATORS
Name Street address City Postal code Country
Frank Tomaka 1125 Trenton Harbourton Road Titusville NJ 08560 United States of America
MAJ Julie Ake, MD 6720A Rockledge Drive Bethesda MD United States of America
Monica Millard R.N., B.S.N., M.P.H. Makerere University-Walter Reed Project Kampala P. O. Box 16524 Uganda
Allan Tindikahwa, B. Pharmacy, CCRC Makerere University Walter Reed Project Kampala P. O. Box 16524 Uganda
Lindsey Baden, MD 15 Francis Street Boston MA 02115 United States of America
Arthur Sekiziyivu M.B.Ch.B, Msc. Epid. Makerere University-Walter Reed Project Kampala PO Box 16524 Uganda
Lawrence Karemani Makerere University-Walter Reed Project Kampala PO Box 16524 Uganda
Hannah Kibuuka, M.B.Ch.B., M.MED., M.P.H. Makerere University Kampala PO Box 16524 Uganda
Salim Wakabi M.B.CH.B Makerere University Kampala PO Box 16524 Uganda
Moses R. Kamya, MBChB, M. Med, MPH, Ph.D Mulago Hospital Complex, Kampala PO Box 7051 Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Arthur Sekiziyivu ASekiziyivu@muwrp.org 256-414-534-588 256-414-534-586
Street address City Postal code Country Position / Affiliation
Makerere University-Walter Reed Project Kampala PO BOX 16524 Uganda Site Principal Investigator
Role Name Email Phone Fax
Public Enquiries Mr Maxwell Gough mgough1@its.jnj.com 41 31 9806273
Street address City Postal code Country Position / Affiliation
Rehhagstrasse 79 Bern 3018 Switzerland Manager Scientific Writing
Role Name Email Phone Fax
Scientific Enquiries Dr frank Tomaka ftomaka@its.jnj.com 1 609 730-7548
Street address City Postal code Country Position / Affiliation
1125 Trenton Harbourton Road Titusville NJ 08560 United States of America Medical Leader