A phase I/II trial to compare the immunogenicity and safety of three DNA C prime followed by one NYVAC C boost to two DNA C prime followed by two NYVAC C boost

EuroVacc Foundation (Switzerland)0 个研究点目标入组 140 人开始时间: 2007年6月29日最近更新: 2019年5月5日

试验速览

•1. Age between 18 and 55 on the day of screening
•2. Available for follow-up for the duration of the study (78 weeks from screening)
•3. Able to give written informed consent
•4. At low risk of HIV and willing to remain so for the duration of the study
•5. Willing to undergo a HIV test
•6. Willing to undergo a genital infection screen
•7. If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IntraUterine Contraceptive Device [IUCD]; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
•8. If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

•1. Pregnant or lactating
•2. Clinically relevant abnormality on history or examination including history of:
•2.1. Grand-mal epilepsy
•2.2. Severe eczema
•2.3. Allergy to eggs or gentamicin
•2.4. Severe allergic diseases
•2.5. Liver disease with inadequate hepatic function
•2.6. Haematological, metabolic or gastrointestinal disorders
•2.7. Uncontrolled infection
•2.8. Autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months
•3. Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
•4. Receipt of blood products or immunoglobin within 4 months of screening
•5. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
•6. History of severe local or general reaction to vaccination
•7. HIV 1/2 positive or indeterminate on screening
•8. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
•9. Positive for DNA/antinuclear (ANA) antibodies at titre considered clinically relevant by immunology laboratory
•10. Grade 1 or above routine laboratory parameters
•11. Unlikely to comply with protocol

发起方

EuroVacc Foundation (Switzerland)