Trial Outcomes & Findings for Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults (NCT NCT02562482)

Last Updated: 2020-10-22

Results Overview

Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

400 participants

Primary outcome timeframe

7 days after any injection

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Overall Study STARTED	201	199
Overall Study Received 1st Injection	197	199
Overall Study Received 2nd Injection	192	192
Overall Study COMPLETED	180	183
Overall Study NOT COMPLETED	21	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Overall Study Enrolled, but did not receive product	4	0
Overall Study Lost to Follow-up	9	6
Overall Study Moved from area	2	3
Overall Study Withdrawal by Subject	5	3
Overall Study Physician Decision	1	3
Overall Study Illness/Injury unrelated to product	0	1

Baseline Characteristics

Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=201 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=199 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.	Total n=400 Participants Total of all reporting groups
Age, Customized 18-20 years	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Age, Customized 21-30 years	66 Participants n=5 Participants	75 Participants n=7 Participants	141 Participants n=5 Participants
Age, Customized 31-40 years	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Age, Customized 41-50 years	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Age, Customized 51-60 years	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	103 Participants n=7 Participants	199 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	96 Participants n=7 Participants	201 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	137 Participants n=5 Participants	138 Participants n=7 Participants	275 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	61 Participants n=7 Participants	125 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/Ethnicity, Customized North, South or Central American Native	144 Participants n=5 Participants	143 Participants n=7 Participants	287 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Haiti	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment Puerto Rico	85 Participants n=5 Participants	87 Participants n=7 Participants	172 Participants n=5 Participants
Region of Enrollment Guadeloupe	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Dominican Republic	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Region of Enrollment Martinique	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Body Mass Index (BMI) under 18.5 kg/m^2	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Body Mass Index (BMI) 18.5-24.9 kg/m^2	94 Participants n=5 Participants	93 Participants n=7 Participants	187 Participants n=5 Participants
Body Mass Index (BMI) 25.0-29.9 kg/m^2	56 Participants n=5 Participants	57 Participants n=7 Participants	113 Participants n=5 Participants
Body Mass Index (BMI) 30.0 kg/m^2 or over	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Body Mass Index (BMI) Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days after any injection

Population: Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=198 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Pain/Tenderness · None	136 Participants	161 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Pain/Tenderness · Mild	58 Participants	37 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Pain/Tenderness · Moderate	3 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Pain/Tenderness · Severe	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Swelling · None	192 Participants	197 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Swelling · Mild	2 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Swelling · Moderate	3 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Swelling · Severe	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Redness · None	196 Participants	198 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Redness · Mild	1 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Redness · Moderate	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Redness · Severe	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Local Symptom · None	133 Participants	161 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Local Symptom · Mild	58 Participants	36 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Local Symptom · Moderate	6 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Local Symptom · Severe	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days after any injection

Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=198 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Myalgia · Severe	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Malaise · None	144 Participants	150 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Malaise · Mild	46 Participants	41 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Malaise · Moderate	7 Participants	7 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Malaise · Severe	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Myalgia · None	151 Participants	162 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Myalgia · Mild	41 Participants	34 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Myalgia · Moderate	5 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Headache · None	143 Participants	140 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Headache · Mild	42 Participants	47 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Headache · Moderate	11 Participants	11 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Headache · Severe	1 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Chills · None	180 Participants	186 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Chills · Mild	13 Participants	10 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Chills · Moderate	4 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Chills · Severe	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Nausea · None	186 Participants	182 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Nausea · Mild	8 Participants	12 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Nausea · Moderate	3 Participants	4 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Nausea · Severe	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Joint Pain · None	173 Participants	184 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Joint Pain · Mild	20 Participants	12 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Joint Pain · Moderate	4 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Joint Pain · Severe	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Temperature · None	188 Participants	193 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Temperature · Mild	7 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Temperature · Moderate	2 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Temperature · Severe	0 Participants	1 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Systemic Symptom · None	110 Participants	113 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Systemic Symptom · Mild	65 Participants	68 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Systemic Symptom · Moderate	21 Participants	16 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection Any Systemic Symptom · Severe	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 4 weeks after last injection

Population: Population included all enrolled subjects who had laboratory results available at any study visit post baseline.

Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=194 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=197 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects With an Abnormal Laboratory Result Lymphocytes	7 Participants	4 Participants
Number of Subjects With an Abnormal Laboratory Result Eosinophils	10 Participants	5 Participants
Number of Subjects With an Abnormal Laboratory Result RBC	28 Participants	21 Participants
Number of Subjects With an Abnormal Laboratory Result ALT	7 Participants	4 Participants
Number of Subjects With an Abnormal Laboratory Result WBC	21 Participants	18 Participants
Number of Subjects With an Abnormal Laboratory Result Hemoglobin	50 Participants	70 Participants
Number of Subjects With an Abnormal Laboratory Result Platelets	6 Participants	4 Participants
Number of Subjects With an Abnormal Laboratory Result Neutrophils	32 Participants	30 Participants
Number of Subjects With an Abnormal Laboratory Result Hematocrit	39 Participants	45 Participants
Number of Subjects With an Abnormal Laboratory Result MCV	28 Participants	23 Participants
Number of Subjects With an Abnormal Laboratory Result Monocytes	5 Participants	6 Participants
Number of Subjects With an Abnormal Laboratory Result Basophils	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 72 weeks after first injection

Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for "Any AE" is the number of subjects reporting at least one or more AEs.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=198 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Renal and urinary disorders	0 Participants	2 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Reproductive system and breast disorders	0 Participants	2 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Respiratory, thoracic and mediastinal disorders	9 Participants	4 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Skin and subcutaneous tissue disorders	3 Participants	9 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Surgical and medical procedures	1 Participants	1 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Vascular disorders	15 Participants	13 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Any AE	104 Participants	111 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Blood and lymphatic system disorders	45 Participants	46 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Cardiac disorders	7 Participants	14 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Endocrine disorders	1 Participants	0 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Eye disorders	2 Participants	0 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Gastrointestinal disorders	11 Participants	11 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) General disorders & administration site conditions	2 Participants	4 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Infections and infestations	33 Participants	39 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Injury, poisoning & procedural complications	6 Participants	4 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Investigations	5 Participants	2 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Metabolism and nutrition disorders	0 Participants	1 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Musculoskeletal and connective tissue disorders	5 Participants	4 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Neoplasms benign, malignant and unspecified	0 Participants	1 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Nervous system disorders	3 Participants	4 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Pregnancy, puerperium & perinatal conditions	1 Participants	0 Participants
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Psychiatric disorders	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 72 weeks after first injection

SAEs were reported from receipt of first study injection through the last expected study visit at 72 weeks. Grading (Mild, Moderate, Severe, Life-threatening, and Death) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple SAEs is counted only once.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=198 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects Reporting Serious Adverse Events (SAEs) Related to study product	0 Participants	0 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs) Unrelated to study product	4 Participants	11 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 72 weeks after first injection

Population: Population included all enrolled subjects who received at least one injection. Four subjects in Group 1 did not receive product.

Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=199 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Subjects who received 2 injections within window as assigned by the randomization schedule and didn't experience any other major protocol deviations prior to Week 8 visit, including those that were CHIKV-infected prior to receipt of 2nd injection who didn't experience deviations prior to infection. None were CHIKV-infected prior to 2nd injection.

Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=182 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=181 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population	2088.2 titer Interval 1765.2 to 2474.1	41.1 titer Interval 30.3 to 55.8

SECONDARY outcome

Timeframe: Week 8

Population: Intent-to-Treat (ITT) population included all enrolled subjects, analyzed according to the randomized vaccine, with immunogenicity data.

Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=193 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=193 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population	1995.7 titer Interval 1673.9 to 2379.3	42.6 titer Interval 31.6 to 57.5

SECONDARY outcome

Timeframe: 4 weeks after last study injection

Population: Modified Intent-to-Treat (mITT) population included all enrolled subjects who received at least one injection with non-missing immunogenicity data at their Week 8 visit, without exclusions for protocol deviations or censoring for CHIKV infection

Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.

Outcome measures

Outcome measures
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=192 Participants Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=192 Participants Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat	2004.5 titer Interval 1680.1 to 2391.5	42.8 titer Interval 31.7 to 57.9

Adverse Events

Group 1: VRC-CHKVLP059-00-VP 20 mcg

Serious events: 4 serious events

Other events: 123 other events

Deaths: 0 deaths

Group 2: Placebo (VRC-PBSPLA043-00-VP)

Serious events: 11 serious events

Other events: 128 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: VRC-CHKVLP059-00-VP 20 mcg n=197 participants at risk Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).	Group 2: Placebo (VRC-PBSPLA043-00-VP) n=198 participants at risk Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Blood and lymphatic system disorders Anaemia	10.2% 20/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	14.6% 29/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Blood and lymphatic system disorders Neutropenia	5.1% 10/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	5.1% 10/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Cardiac disorders Bradycardia	2.5% 5/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	5.6% 11/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Infections and infestations Upper Respiratory Tract Infection	6.1% 12/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	6.6% 13/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
General disorders Administration Site Pain/Tenderness	31.0% 61/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	18.7% 37/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
General disorders Malaise	26.9% 53/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	24.2% 48/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Musculoskeletal and connective tissue disorders Myalgia	23.4% 46/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	18.2% 36/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Nervous system disorders Headache	27.4% 54/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	29.3% 58/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
General disorders Chills	8.6% 17/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	6.1% 12/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Gastrointestinal disorders Nausea	5.6% 11/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	8.1% 16/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
Musculoskeletal and connective tissue disorders Joint Pain	12.2% 24/197 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.	7.1% 14/198 • Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.

Additional Information

Dr. Grace Chen, Deputy Chief, Clinical Trials Program, Vaccine Research Center

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Phone: 240-669-2809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place