Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT01407497
• Date of registration: 01/08/2011
• Primary sponsor: Instituto Nacional de Saúde, Mozambique
• Public title: Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine
• Scientific title: A Phase I Trial to Assess Safety and Immunogenicity of i.d. DNA Priming and i.m. MVA Boosting in Healthy Volunteers in Mozambique and to Develop Further HIV Vaccine Trial Capacity Building in Mozambique
• Date of first enrolment: August 2011
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01407497
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Mozambique

Contacts

• Name: Nafissa Osman, MD, PhD
• Affiliation: Hospital Central de Maputo

• Name: Ilesh Jani, PhD
• Affiliation: Instituto Nacional de Saúde

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age: 18 to 26 years

2. Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing

3. Have a negative antigen/antibody or antibody ELISA for HIV infection

4. Able to give informed consent

5. Satisfactory completion of an assessment of understanding prior to enrolment defined
as 89% correct answers after three opportunities to take the test

6. Basic abilities to read and write

7. Resident in Maputo, and willing to remain so for the duration of the study

8. At low risk of HIV infection, defined as the absence of an identifiable risk factor/
behavior (their presence is therefore an exclusion criteria):

- sexual partner with HIV

- sexual partner with unknown HIV serostatus who is also unwilling to use
protective condoms consistently in all sexual relations

- sexual partner is known to be at high risk for HIV

- more than one sexual partner in the last 6 months

- history of being an alcoholic [as medically defined or more than 35 units /week]

- history of Sexually Transmitted Infection (STI) within past 6 months

9. Verbal assurances that adequate birth control methods are used not to conceive/father
a child during the study and up to 3 months after the last vaccine injection.

10. Women shall have a negative urine pregnancy test

11. Be willing to practice safe sex for the duration of the study to avoid sexually
transmitted infections including HIV

12. Good health as determined by medical history, physical examination, clinical judgment
and by key laboratory parameters as judged by the study physician.

13. Laboratory criteria:

- Hemoglobin >10.5g/dl

- White blood cell count <13,000/mm3

- Neutrophils >1,300/mm3

- Lymphocytes >1.000/ mm3

- Platelets >120,000/ mm3

- Random Blood Glucose < 6.44 mmol/L; if elevated, then a Fasting Blood Glucose <
6.11mmol/L (according to DAIDS Table for Lab Criteria)

- Bilirubin <1.25 x uln

- Alanine transaminase (ALT) <1.25 x uln

- Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+,
complete urinalysis (UA) will be performed.

Exclusion Criteria:

1. At risk of HIV infection as mentioned above in the inclusion criteria

2. Active tuberculosis or other systemic infectious process elicited by review of
systems, physical examination and laboratory detection

3. A history of immunodeficiency, chronic illness requiring continuous or frequent
medical intervention

4. Autoimmune disease by history and physical examination

5. Hives or recurrent hives and severe eczema

6. A history of psychiatric, medical (including traditional medicine) and/or substance
abuse problems during the past 6 months that the investigator believes would
adversely affect the volunteer's ability to participate in the trial

7. History of epilepsy, or currently taking anti-epileptics

8. Received blood or blood products or immunoglobulins in the past 3 months

9. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer
chemotherapy

10. Use of experimental therapeutic agents within 30 days of study entry

11. Reception of any live, attenuated vaccine within 60 days of study entry.

12. Abnormality in Electrocardiogram (ECG) that could indicate risk or make
interpretation of vaccine effects difficult according to the study operating
procedures

13. Previously received an HIV vaccine candidate

14. History of severe local or general reaction to vaccination defined as:

- Local: Extensive, indurate redness and swelling involving most of the major
circumference of the arm, not resolving within 72 hours

- General: Fever >= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal
edema; collapse; convulsions or encephalopathy within 72 hours

15. Being a lactating mother

16. Study site employees who are involved in the protocol and may have direct access to
the immunogenicity results

17. Unlikely to comply with protocol as judged by the principal investigator or his
designate.



Age minimum: 18 Years
Age maximum: 26 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: DNA HIVIS and MVA-CMDR

Biological: Saline solution

Primary Outcome(s)

Adverse events (local and system reactogenicity) [Time Frame: 44 weeks]

Immunogenicity [Time Frame: 44 weeks]

Secondary ID(s)

TAMOVAC-01-MZ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European and Developing Countries Clinical Trials Partnership (EDCTP)

Swedish Institute for Communicable Disease Control, Sweden