Created at Source Raw Value Validated value
March 26, 2021, 2:21 p.m. oms

• Frontline Staff as defined by the Government of Kenya (including healthcare workers, allied health professionals, truckers, security personnel, banking personnel, supermarket staff, police, security personnel, prison workers, laboratory technicians, scientists, logistics personnel, public transport workers including aviation industry amongst others) and other members of public. • Healthy adults aged 18-55 years for phase Ib, =18 years for phase II. • Able and willing (in the Investigators’ opinion) to comply with all study requirements, including making visits to KEMRI CGMRC or other designated study health facility for follow up under conditions with limited transport. • Agreement to refrain from blood donation during the course of the study • Use of effective method of contraception for duration of study for female participants. They should use effective contraception for 30 days prior to vaccination. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device or intrauterine system, male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous, male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). • Provide written informed consent. • Plan to remain resident in the study area for 1 year following vaccination

• Frontline Staff as defined by the Government of Kenya (including healthcare workers, allied health professionals, truckers, security personnel, banking personnel, supermarket staff, police, security personnel, prison workers, laboratory technicians, scientists, logistics personnel, public transport workers including aviation industry amongst others) and other members of public. • Healthy adults aged 18-55 years for phase Ib, =18 years for phase II. • Able and willing (in the Investigators’ opinion) to comply with all study requirements, including making visits to KEMRI CGMRC or other designated study health facility for follow up under conditions with limited transport. • Agreement to refrain from blood donation during the course of the study • Use of effective method of contraception for duration of study for female participants. They should use effective contraception for 30 days prior to vaccination. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device or intrauterine system, male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous, male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). • Provide written informed consent. • Plan to remain resident in the study area for 1 year following vaccination

Oct. 26, 2020, 8:29 a.m. oms

• Frontline Staff as defined by the Government of Kenya • Healthy adults aged 18-55 years for phase Ib, =18 years for phase II. • Able and willing (in the Investigators’ opinion) to comply with all study requirements, including making visits to KEMRI CGMRC or other designated study health facility for follow up under conditions with limited transport. • Agreement to refrain from blood donation during the course of the study • Use of effective method of contraception for duration of study for female participants. They should use effective contraception for 30 days prior to vaccination. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device or intrauterine system, male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous, male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). • Provide written informed consent. • Plan to remain resident in the study area for 1 year following vaccination

• Frontline Staff as defined by the Government of Kenya • Healthy adults aged 18-55 years for phase Ib, =18 years for phase II. • Able and willing (in the Investigators’ opinion) to comply with all study requirements, including making visits to KEMRI CGMRC or other designated study health facility for follow up under conditions with limited transport. • Agreement to refrain from blood donation during the course of the study • Use of effective method of contraception for duration of study for female participants. They should use effective contraception for 30 days prior to vaccination. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device or intrauterine system, male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous, male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). • Provide written informed consent. • Plan to remain resident in the study area for 1 year following vaccination