A Phase IIa Observer-blind, Randomized, Controlled, Age-de-escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, Including Dose-finding in Infants, in Africa

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug, Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then on children (24-59 months of age) and finally to infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 50
Healthy Volunteers: t
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⁃ All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:

• Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).

• Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.

• Healthy participants as established by medical history, clinical examination, and laboratory investigations.

• Participants satisfying screening requirements.

• Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

⁃ Adult participants must satisfy ALL the following criteria at study entry:

• A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.

• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female participants of childbearing potential may be enrolled in the study if the participant:

⁃ has practiced adequate contraception for 1 month prior to study intervention administration, and:

• has a negative pregnancy test on the day of study intervention administration, and

• has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.

⁃ The Ghana card will be used as source document to verify the ages for the adults.

⁃ Child participants must satisfy ALL the following criteria at study entry:

• A male or female between and including 24 and 59 months of age at the time of the first study intervention administration.

• Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR's.

• Born after a gestation period of ≥37 weeks.

⁃ Infant participants must satisfy ALL the following criteria at study entry:

• A male or female 6 weeks or 9 months of age at the time of the first study intervention administration.

• Born after a gestation period of ≥37 weeks.

• Born to a mother seronegative for HIV, hepatitis B virus and hepatitis C virus.

⁃ The Road to Health Chart will be used as source document to confirm the ages for the children and infants.

Locations
Other Locations
Ghana
GSK Investigational Site
RECRUITING
Kumasi
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2026-04-27
Participants
Target number of participants: 516
Treatments
Experimental: Adults_Dose C Group
Adults 18-50 years of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57.
Active_comparator: Adults_Control Group
Adults 18-50 years of age, part of the safety cohort, randomized to receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57.
Experimental: Children_Dose B Group
Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose B vaccine at Day 1 and Day 57.
Active_comparator: Children_Control B Group
Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Experimental: Children_Dose C Group
Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57.
Active_comparator: Children_Control C Group
Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Experimental: Infants_9M_Dose A Group
Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 85 and Day 169. These infants also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_9M_Control A Group
Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_9M_Dose B Group
Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_9M_Control B Group
Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_9M_Dose C Group
Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_9M_Control C Group
Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose A Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_6W_Control A Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose B Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_6W_Control B Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose C Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_6W_Control C Group
Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose A_2 Group
Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose B_2 Group
Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Experimental: Infants_6W_Dose C_2 Group
Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Active_comparator: Infants_6W_Control_2 Group
Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Sponsors
Collaborators: Kwame Nkrumah University of Science and Technology, Pedvac iNTS consortium, European & Developing Countries Clinical Trials Partnership
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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