Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212801139469 Date of Registration: 13/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Moderna TX
Official scientific title A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to < 18 years of age
Brief summary describing the background and objectives of the trial The Sponsor’s scalable mRNA/LNP technology platform allowed for a rapid response to the COVID-19 pandemic and was used to develop mRNA-1273, a novel LNP-encapsulated mRNA-based vaccine against SARS-CoV-2. The Sponsor’s mRNA/LNP platform is based on the principle and observations that cells in vivo can take up mRNA, translate it, and then express protein viral antigen(s) on the cell surface. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently. Vaccine mRNA-1273 encodes for the full-length spike (S) protein SARS-CoV-2(CoV S). The CoV S protein mediates attachment and entry of the virus into host cells, by binding to the angiotensin converting enzyme 2 receptor followed by membrane fusion, making it a primary target for nAb that prevents infection (Johnson et al 2016; Wang et al 2015; Wang et al 2018; Chen et al 2017; Corti et al 2015; Yu et al 2015; Kim et al 2019; Widjaja et al 2019; Corbett et al 2020a; Ju et al 2020; Robbiani et al 2020). Primary Objectives: - To evaluate the safety and reactogenicity of 100 g mRNA-1273 vaccine administered in 2 doses 28 days apart - To infer efficacy of mRNA-1273 (100 µg, 2 doses 28 days apart), serum Ab responses obtained 28 days after the second injection of mRNA-1273 (Day 57) will be either:  Evaluated against an accepted Ab threshold of protection against COVID-19 (if established in Study P301)  Compared in primary vaccine response as measured by GM values of serum Ab and SRR in Study P203 with those obtained from young adult recipients (18 to 25 years of age) of mRNA-1273 in the clinical clinical endpoint efficacy trial (Study P301)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) mRNA
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/08/2023
Actual trial start date
Anticipated date of last follow up 28/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mRNA1273 0.5 mL consisting of either 100 µg dose of mRNA-1273 2 doses of IP by IM injection, 28 days apart (ie, Day 1 and Day 29) into the deltoid muscle, according to their assigned regimen In the Blinded Phase, Part 1A of the study, each participant will receive 2 doses of IP by IM injection, 28 days apart (ie, Day 1 and Day 29) into the deltoid muscle, according to their assigned regimen and according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, both doses should be administered into the nondominant arm. In the open-label Part 1B of the study, mRNA-1273 vaccine will be administered as an IM injection into the deltoid muscle following the injection schedule for each group based on the product received in Part 1A. Participants who received placebo in Part 1A will receive 2 doses of mRNA-1273 (100 µg) on OL – Day 1 and OL-Day 29 of Part 1B (Table 12). Preferably, both doses should be administered into the nondominant arm. For Part 1C, mRNA-1273 vaccine will be administered as an IM injection into the deltoid muscle. Preferably, the dose should be administered into the nondominant arm. Each injection will have a volume of 0.25 mL and contain mRNA-1273 50 µg. For Part 2, each participant will receive 2 doses of 50 µg mRNA-1273 by IM injection, 28 days apart (ie, Day 1, Day 29) into the deltoid muscle, according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, all doses should be administered into the nondominant arm. For Part 3, each participant will receive 2 doses of 50 µg mRNA-1273.222 by IM injection, 6 months apart (ie, Day 1, Day 181) into the deltoid muscle, according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, all doses should be administered into the nondominant arm. At each visit when IP is administered, participants will be monitored for a minimum of 30 minutes after administration. Assessments will include vital sign measurements and monitoring for local or systemic reactions (Table 10, Table 12, Table 13, Table 14, and Table 15). 333
Control Group Placebo group 0.5 mL consisting of 100 µg dose of placebo (normal saline), as detailed in the mRNA-1273-P203 Pharmacy Manual In the Blinded Phase, Part 1A of the study, each participant will receive 2 doses of IP by IM injection, 28 days apart (ie, Day 1 and Day 29) into the deltoid muscle, according to their assigned regimen and according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, both doses should be administered into the nondominant arm. In the Blinded Phase, Part 1A of the study, each participant will receive 2 doses of IP by IM injection, 28 days apart (ie, Day 1 and Day 29) into the deltoid muscle, according to their assigned regimen and according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, both doses should be administered into the nondominant arm. In the open-label Part 1B of the study, mRNA-1273 vaccine will be administered as an IM injection into the deltoid muscle following the injection schedule for each group based on the product received in Part 1A. Participants who received placebo in Part 1A will receive 2 doses of mRNA-1273 (100 µg) on OL – Day 1 and OL-Day 29 of Part 1B (Table 12). Preferably, both doses should be administered into the nondominant arm. For Part 1C, mRNA-1273 vaccine will be administered as an IM injection into the deltoid muscle. Preferably, the dose should be administered into the nondominant arm. Each injection will have a volume of 0.25 mL and contain mRNA-1273 50 µg. For Part 2, each participant will receive 2 doses of 50 µg mRNA-1273 by IM injection, 28 days apart (ie, Day 1, Day 29) into the deltoid muscle, according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, all doses should be administered into the nondominant arm. For Part 3, each participant will receive 2 doses of 50 µg mRNA-1273.222 by IM injection, 6 months apart (ie, Day 1, Day 181) into the deltoid muscle, according to the procedures specified in the mRNA-1273-P203 Pharmacy Manual. Preferably, all doses should be administered into the nondominant arm. At each visit when IP is administered, participants will be monitored for a minimum of 30 minutes after administration. Assessments will include vital sign measurements and monitoring for local or systemic reactions (Table 10, Table 12, Table 13, Table 14, and Table 15). 167 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: 1. Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B, and are at least 5 months from the last dose. 2. Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1). Pregnant or breastfeeding. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator’s judgment. History of a diagnosis or condition (after enrollment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety: • Suspected active hepatitis • Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy Adolescent: 13 Year(s)-17 Year(s) 12 Year(s) 18 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/01/2023 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200, NAIROBI, Kenya Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the safety and reactogenicity of 100 g mRNA-1273 vaccine administered in 2 doses 28 days apart Solicited local and systemic ARs through 7 days after each injection Unsolicited AEs through 28 days after each injection MAAEs through the entire study period SAEs through the entire st
Secondary Outcome To evaluate the persistence of the immune response of mRNA-1273 vaccine (100 g) administered in 2 doses 28 days apart, as assessed by the level of SARS-CoV-2 S2P-specific bAb through 1 year after Dose 2 1 year after Dose 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI CRDR Clinical Research Clinic Nairobi Off hospital road Nairobi 00100 Kenya
Kenya Medical Research Institute Kisumu P O Box 1578 Kisumu 40100 Kenya
Kenya Aids Vaccine Initiative kavi Kenyatta National Hospital, Medical Microbiology Nairobi 10700202 Kenya
Kenya Medical Research Institute CMR Kargeno Research and Policy Hub Jairo Street Junction Kisumu 40100 Kenya
Kenya Medical Research Institute Walter Reed Project Clinical Research Center KEMRI WRP CRS Hospital Road Po Box 1357-20200 Kericho 20200 Kenya
Victoria Biomedical Research Institute VIBRI Ring Road Milimani, P.O Box 7180 Kisumu 40100 Kenya
Kenya Medical Research Institute Kisumu-kakamega Road, Kisumu Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
ModernaTX Inc 200 Technology Square Cambridge, MA 02139 Cambridge 200 Techn United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moderna TX Inc 200 Technology Square Cambridge, MA 02139 Cambridge 200 Techn United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Dr. Videlis Nduba vnduba@gmail.com +254722205901 Po Box 47855-00100
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Victopr Mudhune vmudhune@kemricdc.org +254722687430 P O Box 1578
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Maricianah Onono maricianah@gmail.com +254732390992 Jairo Street Junction
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Sponsor shares information about clinical trials and results on publicly accessible websites, based on international and local legal and regulatory requirements, and other clinical trial disclosure commitments established by pharmaceutical industry associations. These websites include clinicaltrials.gov, EU clinical trial register (eu.ctr), as well as some national registries. In addition, results from clinical trials are required to be submitted to peer-reviewed journals following internal company review for accuracy, fair balance, and intellectual property. For those journals that request sharing of the analyzable data sets that are reported in the publication, interested researchers are directed to submit their request to clinicalstudydatarequest.com. Individual participant data and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, the privacy of participants in clinical studies sponsored by the Sponsor is assured. Details on data sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol When the clinical study report is final To be confirmed
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information