TaMoVaC II

Not Applicable

Recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR201211000435126
• Lead Sponsor: Swedish Institute for Infectious Disease Control

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Age: 18 to 40 years
Willing to undergo counselling and HIV testing
Have a negative antigen/antibody ELISA for HIV infection
Able to give informed consent
Basic abilities to read and write.
Satisfactory completion of an assessment of understanding prior to enrolment defined
as 90% correct answers after three opportunities to take test.
Resident in Dar es Salaam, Mbeya or Maputo catchment areas, and willing to remain so
for the duration of the study
At low risk of HIV infection, defined as the absence of an identifiable risk factor/
behaviour according to a risk assessment questionniare.
Verbal assurances that adequate birth control measures are used not to conceive/father
a child during the study and up to 3 months after the last vaccine injection.
Women shall have a negative urinary pregnancy test
Be willing to practice safe sex for the duration of the study to avoid sexually transmitted
infections including HIV

Good health as determined by medical history, physical examination, clinical judgment
and by key laboratory parameters as judged by the study physician.
Laboratory criteria within 8 weeks prior to enrollment

Exclusion Criteria

At risk of HIV infection as mentioned above in the inclusion criteria
Active tuberculosis or other systemic infectious process elicited by review of systems,
physical examination and laboratory detection (for example detection of Hepatitis B
surface antigen or active syphilis).
A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or
chronic illness requiring continuous or frequent medical intervention
Autoimmune disease by history and physical examination.
Hives or recurrent hives and severe eczema
Substance abuse problems (including traditional medicine) during the past 12 months
that in the opinion of the investigator would preclude participation
History of grand-mal epilepsy, or currently taking anti-epileptics
Received blood or blood products or immunoglobulins in the past 3 months.
Receiving immunosuppressive therapy such as systemic corticosteroids or cancer
chemotherapy.
Use of experimental therapeutic agents within 30 days of study entry.
Reception of any live, attenuated vaccine within 60 days of study entry. Medically
indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary
but should be given at least 2 weeks before or after HIV immunisation to avoid potential
confusion of adverse reactions.
History of cardiac disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified