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Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women

ConditionRespiratory Syncytial Virus (RSV)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorMAXVAX Biotechnology Limited Liability Company

About this trial

A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult females 18-49 years old on the day of vaccination.

Generally healthy, as established by medical history and clinical examination before vaccination and absence of unresolved acute disease or acute exacerbation of chronic disease.

Intent to reside in the area of the study site for the throughout the study visits and also available for phone follow ups after vaccination.

Signing an Informed Consent Form indicating that the purpose, procedures and potential risks and benefits of the study have been explained including an opportunity to ask questions.

Disqualifiers

Recent RSV exposure/vaccination: History of RSV infection within 6 months or prior RSV vaccination.

Pregnancy/lactation: Pregnant, breastfeeding, or planning pregnancy within 90 days post-vaccination.

Recent investigational products: Received any investigational product within 30 days or plans study participation during this trial.

Recent vaccines: Live vaccine within 30 days or any other vaccine within 14 days before study vaccination, or planned vaccination within 3 months after.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MKK900 60 µg

    Biological/Vaccine

    Unit Dose Strength: The 60-μg dose vial will have a concentration of 120 μg/mL (0.5 mL injection volume) Route of Administration : Intramuscular Injection

  • MKK900 120 µg

    Biological/Vaccine

    Unit Dose Strength: The 120-μg dose vial will have a concentration of 240 μg/mL (0.5 mL injection volume). Route of Administration : Intramuscular Injection

  • ABRYSVO®

    Biological/Vaccine

    Dose Formulation: Vial of Lyophilized Antigen Component (sterile white power) that is reconstituted at the time of use with a Sterile Water Diluent Component. Unit Dose Strength: 120 µg of RSV stabilized pre-fusion F proteins (60 µg RSV pre-F A and 60 µg RSV pre-F B) per 0.5 mL. Route of Administration: Intramuscular injection

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: MKK900 60 µgExperimental treatment 1 intervention
Group B: MKK900 120 µgExperimental treatment 1 intervention
Group C: ABRYSVOActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of solicited local and systemic adverse events (AEs)

Time frame
during the 7 days following vaccination
2

Frequency of unsolicited adverse events AEs

Time frame
during the 30 days following vaccination
3

Frequency of serious adverse events (SAEs)

Time frame
up to 180 days after vaccine administration

Secondary outcomes

1

Geometric mean titers (GMTs) of neutralizing antibodies against RSV types A and B

Time frame
Day 7, Day 30, and Day 90 post-vaccination.
2

Geometric mean fold rise (GMFR) of neutralizing antibodies against RSV types A and B

Time frame
Day 7, Day 30, and Day 90 post-vaccination.
3

Seroresponse rate of neutralizing antibodies against RSV types A and B

Time frame
Day 7, Day 30, and Day 90 post-vaccination.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MAXVAX Biotechnology Limited Liability Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: