Trial Outcomes & Findings for Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006) (NCT NCT03807843)

NCT ID: NCT03807843

Last Updated: 2022-09-08

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Up to 7 days after vaccination (up to Day 35)

Results posted on

2022-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	V184 Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Overall Study STARTED	21	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	V184 Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V184 n=21 Participants Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=20 Participants Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.	Total n=41 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 13.29 • n=5 Participants	37.3 years STANDARD_DEVIATION 11.37 • n=7 Participants	39.3 years STANDARD_DEVIATION 12.40 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 days after vaccination (up to Day 35)

Population: All participants that received at least one dose of vaccine/placebo were analyzed.

Outcome measures

Outcome measures
Measure	V184 n=21 Participants Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=20 Participants Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Number of Participants With Solicited Adverse Events (AEs)	15 Participants	11 Participants

PRIMARY outcome

Timeframe: Up to Day 196

Population: All participants that received at least one dose of vaccine/placebo were analyzed.

An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.

Outcome measures

Outcome measures
Measure	V184 n=21 Participants Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=20 Participants Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Number of Participants With Unsolicited AEs	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to Day 196

Population: All participants that received at least one dose of vaccine/placebo were analyzed.

An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.

Outcome measures

Outcome measures
Measure	V184 n=21 Participants Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=20 Participants Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Days 0, 28, 56, and 196

Population: All participants that received both doses of vaccine/placebo, had at least one post-vaccination immunogenicity assessment, and did not experience a protocol deviation that affected their immunogenicity evaluation were analyzed.

Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).

Outcome measures

Outcome measures
Measure	V184 n=18 Participants Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=17 Participants Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time Day 28	1.5 Ratio Interval 1.2 to 1.8	0.9 Ratio Interval 0.7 to 1.2
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time Day 56	1.9 Ratio Interval 1.5 to 2.3	0.9 Ratio Interval 0.7 to 1.1
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time Day 196	1.3 Ratio Interval 1.0 to 1.6	1.0 Ratio Interval 0.8 to 1.3

Adverse Events

V184

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After completion of the study, the Investigator may prepare a joint publication with the Sponsor and Project Oversight Agency. The Investigator must not submit any part of the data from this protocol for publication without the prior consent of the Sponsor and Project Oversight Agency.
Publication restrictions are in place

Restriction type: OTHER

Measure	V184 n=21 participants at risk Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10\^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.	Placebo n=20 participants at risk Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
Infections and infestations Corona virus infection	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Chills	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	10.0% 2/20 • Number of events 2 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	14.3% 3/21 • Number of events 4 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	30.0% 6/20 • Number of events 9 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site erythema	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site induration	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site pain	52.4% 11/21 • Number of events 17 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	25.0% 5/20 • Number of events 10 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site pruritus	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Malaise	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	20.0% 4/20 • Number of events 4 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
General disorders Pyrexia	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 6/21 • Number of events 10 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	25.0% 5/20 • Number of events 7 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 3/21 • Number of events 5 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	25.0% 5/20 • Number of events 8 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	19.0% 4/21 • Number of events 4 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	25.0% 5/20 • Number of events 5 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	4.8% 1/21 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	0.00% 0/20 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/21 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • Up to Day 196 All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.