Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults (NCT03392389) | Clinical Trial Compass
CompletedPhase 1
Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults
United States124 participantsStarted 2017-12-04
Plain-language summary
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy adults.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Agrees to comply with the study procedures and provides written informed consent
* 18 to 49 years of age
* Body mass index between 18 and 35 kg/m2
* In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
* Negative urine pregnancy test at the screening visit and the day of each vaccination for females of childbearing potential
* Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 30 days prior to enrollment and through 3 months following last vaccination
* Willing to comply with the requirements of the protocol (eg, complete Diary Cards, return for follow-up visits, be available for safety phone calls)
Exclusion Criteria:
* Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
* A history of malignancy in the last 10 years
* If female and of childbearing potential, is pregnant or lactating, has not adhered to an adequate contraception method from at least 30 days before study entry, or does not plan to do so for at least 3 months after the last vaccination
* Abnormal screening safety laboratory test results including liver enzyme tests
* Administration of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine or has plans for administration during the study pe…
What they're measuring
1
Frequency of solicited AEs (local and systemic reactogenicity events)
Timeframe: 7 days following each dose administration
2
Frequency of unsolicited adverse events
Timeframe: 28 days following each dose administration
3
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs
Timeframe: one year following the last dose administration
4
Frequency of clinical laboratory adverse events
Timeframe: 1 month following the last dose administration
5
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
Timeframe: 1 month following the last dose administration
6
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
Timeframe: 1 month following the last dose administration
7
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline