| Each potential participant must satisfy all of the following criteria to be enrolled in this current study:
1. Must have previously received the 2-dose Ebola vaccine regimen at sites in Kenya or Uganda in Cohort 2a of the VAC52150EBL2002 study.
2. Must be a male or female subject and aged 18 - 50 years at time of randomisation in the parent trial (VAC52150EBL2002).
3. Must consent to participate in the study by signing (or thumbprinting, if illiterate) an informed consent form, indicating that he or she understands the purpose of, and procedures required for, the study, and he/she understands the potential risks and benefits of the study.
4. Must be willing/able to ensure that they adhere to the prohibitions and restrictions specified in the protocol.
5. Must be available and willing to participate for the duration of the study visits.
6. Must be in reasonably good medical condition in the investigator’s clinical judgement.
7. Must be on a stable regimen of HAART taking into account the following criteria (please see protocol for more information).
8. Potential participants must be healthy on the basis of clinical laboratory tests performed at screening (please see protocol for more information).
9. Female subjects of childbearing potential must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before vaccination until the end of the study, with a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test at screening and immediately prior to the vaccination, which shall occur no earlier than 14 days after the screening visit.
10. Must have a means to be contacted |
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Participants in the VAC52150EBL2002 trial who were in any study cohort other than cohort 2a, or were allocated to the placebo arm in Cohort 2a.
2. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine e.g., polysorbate 80, ethylenediaminetetraacetic acid, or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (e.g. gentamicin).
3. Presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38ºC on Day 1.
4. Women who are breast-feeding or known to be pregnant or planning to become pregnant while enrolled in the study or within 1 month after the booster vaccination.
5. Clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
6. Received a blood transfusion or other blood products within 8 weeks of enrolment.
7. Potential participants who have been vaccinated with live-attenuated vaccines within 30 days before and after the study vaccination, and with inactive vaccine within 15 days before and after the study vaccination.
8. Receipt of any disallowed therapies before the planned administration of the vaccine on Day 1.
9. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the study.
10. Any other finding which in the opinion of the investigator would increase the risk of an adverse outcome from participation in the study. |
Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
60 Year(s) |
Both |