Trial no.:	PACTR2009040001075080	Date of Approval:	24/03/2009
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

HIVIS03

Official scientific title

A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in DaresSalaam, Tanzani

Brief summary describing the background and objectives of the trial

Following work in TANSWED Programme funded by Sida/SAREC, in 2001 a EU funded HIVIS project was initiated to develop and evaluate a candidate multi-gene, DNA (A, B, C) prime with MVA {CRF01 A_E}) boost vaccine. A Phase I trial showed excellent safety & immunogenicity in Sweden. Objectives HIVIS03 are to assess safety & immunogenicity; and build capacity in evaluating HIV vaccines in Tanzania.

Type of trial

CCT

Acronym (If the trial has an acronym then please provide)

HIVIS03

Disease(s) or condition(s) being studied

Infections and Infestations

Sub-Disease(s) or condition(s) being studied

HIV/AIDS

Purpose of the trial

Prevention: Vaccines

Anticipated trial start date

20/02/2007

Actual trial start date

Anticipated date of last follow up

21/02/2008

Actual Last follow-up date

Anticipated target sample size (number of participants)

0

Actual target sample size (number of participants)

Recruitment status

Closed to recruitment,follow-up continuing

Publication URL

Secondary Ids	Issuing authority/Trial register

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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomisation using envelopes	Sealed opaque envelopes	Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomisation using envelopes	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Priming with intramuscular DNA, Boosting with intramuscular MVA	DNA at 3.8mg IM by Bioject® device, MVA at 10^8 pfu IM by needle & syringe	DNA at months 0,1 & 3. MVA at months 9 & 21	DNA has 7 plasmids containing HIV-1 env subtype A, B and C, gag subtype A and B, RTmut and rev subtype B. MVA contains analogous HIV-1 genes from subtype A/E.	20
Control Group	Saline	Saline IM by Bioject® device, Saline IM by needle & syringe	Saline at months 0,1 & 3. and then Saline at months 9 & 21	Normal saline as DNA and MVA placebo respectively	10	Placebo
Experimental Group	Priming with intradermal DNA, Boosting with intradermal MVA	DNA at 1.0mg ID by Bioject® device, MVA at 10^8 pfu IM by needle & syringe	DNA at months 0,1 & 3. MVA at months 9 & 21	DNA has 7 plasmids containing HIV-1 env subtype A, B and C, gag subtype A and B, RTmut and rev subtype B. MVA contains analogous HIV-1 genes from subtype A/E.	20
Control Group	Saline	Saline ID by Bioject® device, Saline IM by needle & syringe	Saline at months 0,1 & 3. and then Saline at months 9 & 21	Normal saline as DNA and MVA placebo respectively	10	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
18-40 years Willing to be counseled & HIV tested Negative HIV Ag/Ab ELISA Informed consent Minimum 7 years of 1° Education. Resident in Dar es Salaam At low risk of HIV, (absence of: sexual partner with HIV, partner with unknown HIV serostatus and unwilling to use protection in sexual relations, partner known to be at high risk for HIV, >1 sexual partner in last 6 months, alcoholic (>35 units/week), STI in past 6 months). Assurances for birth control measures till 4 months after last vaccination Negative UPT Willingness for safe sex practice Good health by clinical & lab parameters: (FBG <7.8 mmol/l, Hb >10.5g/dl, WBC count >1,300/mm3, Granulocytes >6.4/ mm3, Lymphocytes >1.0/ mm3, Platelets >120,000/ mm3, CD4 >400cells/mm3, RBG 2.5-7.0 mmol/L; if elevated, then a FBG <7.8 mmol/l, Bilirubin <1.25 x uln, ALT <1.25 x uln, Creatinine <1.25 x uln, -ve/trace urine dipstick for protein and blood)	Active TB/other systemic infection Positive HBsAg Active syphilis Immunodeficiency/chronic illness Autoimmune disease Severe eczema Psychiatric/substance abuse problem in past 6 months Grand-mal epilepsy, or current use of anti-epileptics Blood/Blood products/immunoglobulins use in past 3 months Immunosuppressive therapy. Experimental therapeutic agents within 30 days of study entry Any live, attenuated vaccination within 60 days of study entry Receipt of an HIV candidate vaccine. Severe local or general reaction to vaccination Lactating mothers Study site employees Protocol non-compliance				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

Yes

30/01/2006

National Ethics Committee at the National Institute for Medical Research (NIMR). The study was approved on 30/01/2006 (ref: NIMR/HQ/R.8a Vol.IX/410). As of 19/08/2008, the last amendments were approved on 19/06/2008 (ref: MU/DRP/PA/ Vol.I/37)

Ethics Committee Address
Street address	City	Postal code	Country
Ocean Road	Dar es Salaam	P.O. Box 9653	United Republic of Tanzania