Trial Outcomes & Findings for A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI (NCT NCT05604521)

Last Updated: 2024-11-25

Results Overview

The differences in proportions of vaccinees compared to controls experiencing related moderate, severe, or serious solicited and unsolicited adverse events and laboratory abnormalities after vaccination.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

Day of immunization to 28 days post immunization

Results posted on

2024-11-25

Participant Flow

Altogether, 72 persons were screened, 31 received immunizations, 15 were screen failures, 4 were eligible but yet not enrolled, and 22 were still being evaluated when the study was terminated.

Participant milestones

Participant milestones
Measure	Group 1: PfSPZ Vaccine N=24; received at least 1 dose of vaccine.	Group 2: Normal Saline Placebo N=7; received normal saline placebo
Overall Study STARTED	24	7
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	24	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: PfSPZ Vaccine N=24; received at least 1 dose of vaccine.	Group 2: Normal Saline Placebo N=7; received normal saline placebo
Overall Study Trial terminated early due to an extended gap between the 2nd and 3rd doses (3rd dose not given).	23	7
Overall Study Adverse Event	1	0

Baseline Characteristics

A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: PfSPZ Vaccine n=24 Participants N=24; received at least 1 dose of vaccine.	Group 2: Normal Saline Placebo n=7 Participants N=7; received normal saline placebo	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	7 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	4 Participants n=7 Participants	18 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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
Region of Enrollment United States	24 Participants n=5 Participants	7 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of immunization to 28 days post immunization

Population: 24 participants received a 1st dose and 23 participants received a 2nd dose of vaccine, and 7 participants received 2 doses of placebo. Due to early study termination, we measured outcome variables for which data were available: proportion of participants experiencing local solicited AEs, systemic solicited AEs and related unsolicited AEs.

Outcome measures

Outcome measures
Measure	Group 1: PfSPZ Vaccine n=24 Participants N=24; received at least 1 dose of vaccine.	Group 2: Normal Saline Placebo n=7 Participants N=7; received normal saline placebo
Adverse Events	17 Participants	7 Participants

Adverse Events

Group 1: PfSPZ Vaccine

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 2: Normal Saline Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Sanaria Inc.

Phone: 301-770-3222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee (1) The principal investigator and associated institution are restricted from using the results of the study for commercial purposes; (2) the principal investigator is obligated to provide the Sponsor an opportunity to review planned disseminations of the data for "confidential information" that if present must be removed on Sponsor's request; (3) it is stipulated that communications such as publications and presentations should be "joint."
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Group 1: PfSPZ Vaccine n=24 participants at risk N=24; received at least 1 dose of vaccine.	Group 2: Normal Saline Placebo n=7 participants at risk N=7; received normal saline placebo
Immune system disorders Allergic reaction - hypersensitivity	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Nervous system disorders Dizziness	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Bruising	29.2% 7/24 • Number of events 9 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	71.4% 5/7 • Number of events 8 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Erythema	20.8% 5/24 • Number of events 6 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	57.1% 4/7 • Number of events 4 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Pain	12.5% 3/24 • Number of events 3 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	28.6% 2/7 • Number of events 2 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Swelling	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	14.3% 1/7 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Tenderness	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Fatigue	33.3% 8/24 • Number of events 8 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	57.1% 4/7 • Number of events 4 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Musculoskeletal and connective tissue disorders Arthralgia	20.8% 5/24 • Number of events 5 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Chills	16.7% 4/24 • Number of events 4 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	14.3% 1/7 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Subjective fever	25.0% 6/24 • Number of events 6 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	28.6% 2/7 • Number of events 2 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Nervous system disorders Headache	37.5% 9/24 • Number of events 12 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	42.9% 3/7 • Number of events 3 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Malaise	29.2% 7/24 • Number of events 9 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	42.9% 3/7 • Number of events 3 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Musculoskeletal and connective tissue disorders Myalgia	37.5% 9/24 • Number of events 11 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	57.1% 4/7 • Number of events 5 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Rigors	20.8% 5/24 • Number of events 5 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	14.3% 1/7 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Skin and subcutaneous tissue disorders Systemic allergic type reaction - dermatographia	4.2% 1/24 • Number of events 2 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
Skin and subcutaneous tissue disorders Systemic allergic type reaction - feet pruritis	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	0.00% 0/7 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).
General disorders Fever	4.2% 1/24 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).	14.3% 1/7 • Number of events 1 • Solicited local adverse events (AEs) were collected for two days after each immunization. Solicited systemic AEs were collected for 7 days after each immunization. Unsolicited AEs were collected from the first immunization to 28 days after the second immunization (since the study was terminated early). SAEs were to be recorded through the entire duration of the trial. Solicited local AEs: pain \& pruritus (by questioning participant), tenderness \& induration (by palpation) \& erythema, bruising \& swelling (by visual inspection, swelling by viewing site laterally for swelling of skin). Solicited systemic AEs: fever (oral temp \> 100.4 F), subjective fever, chills, headache, fatigue, malaise, myalgia, arthralgia, rigors, systemic allergic type reactions (rash, urticaria, pruritus, edema). Unsolicited AEs: open-ended question (e.g.do you have any other symptoms?).