Trial Outcomes & Findings for Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART (NCT NCT05604209)

Last Updated: 2025-08-24

Results Overview

The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs were assessments that were considered related to study product as possible, probable, or definite as defined in the protocol. Confidence intervals around percentages were estimated using the Clopper-Pearson exact method.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

First day of study treatment through 28 days following last vaccination, an average of 2 months

Results posted on

2025-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	C62-M4 ChAdOx1.HIVconsv62 (C62) vaccine administered at Day 0, followed by MVA.tHIVconsv4 (M4) vaccine administered at Day 28 ChAdOx1.HIVconsv62: Administered intramuscularly (IM) at Day 0 MVA.tHIVconsv4: Administered intramuscularly (IM) at Day 28	C1C62-M3M4 ChAdOx1.tHIVconsv1 (C1) and ChAdOx1.HIVconsv62 (C62) vaccines administered at Day 0, followed by MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) vaccines administered at Day 28 ChAdOx1.tHIVconsv1: Administered intramuscularly (IM) at Day 0 ChAdOx1.HIVconsv62: Administered intramuscularly (IM) at Day 0 MVA.tHIVconsv3: Administered intramuscularly (IM) at Day 28 MVA.tHIVconsv4: Administered intramuscularly (IM) at Day 28	Placebo Placebo administered on Day 0 and Day 28 Placebo: Administered at intramuscularly (IM) Day 0 and Day 28
Overall Study STARTED	8	8	2
Overall Study Enrollment Leukapheresis	8	8	2
Overall Study Day 0 Vaccination	8	8	2
Overall Study Day 28 Vaccination	8	8	2
Overall Study Day 56 Leukapheresis/Large Volume Blood Draw	8	8	2
Overall Study COMPLETED	8	8	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C62-M4 n=8 Participants ChAdOx1.HIVconsv62 (C62) vaccine administered at Day 0, followed by MVA.tHIVconsv4 (M4) vaccine administered at Day 28 ChAdOx1.HIVconsv62: Administered intramuscularly (IM) at Day 0 MVA.tHIVconsv4: Administered intramuscularly (IM) at Day 28	C1C62-M3M4 n=8 Participants ChAdOx1.tHIVconsv1 (C1) and ChAdOx1.HIVconsv62 (C62) vaccines administered at Day 0, followed by MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) vaccines administered at Day 28 ChAdOx1.tHIVconsv1: Administered intramuscularly (IM) at Day 0 ChAdOx1.HIVconsv62: Administered intramuscularly (IM) at Day 0	Placebo n=2 Participants Placebo administered on Day 0 and Day 28 Placebo: Administered at intramuscularly (IM) Day 0 and Day 28	Total n=18 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	33.5 years n=7 Participants	50.5 years n=5 Participants	50 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	18 Participants n=4 Participants

PRIMARY outcome

Timeframe: First day of study treatment through 28 days following last vaccination, an average of 2 months

Population: All participants that received C62-M4, C1C62-M3M4, or placebo were included.

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=8 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo n=2 Participants Placebo administered on Day 0 and Day 28
Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)	12.5 percentage of participants Interval 0.32 to 52.7	0 percentage of participants Interval 0.0 to 36.9	0 percentage of participants Interval 0.0 to 84.2

SECONDARY outcome

Timeframe: First day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

Population: All participants that received C62-M4, C1C62-M3M4, or placebo were included.

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=8 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo n=2 Participants Placebo administered on Day 0 and Day 28
Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE)	87.5 percentage of participants Interval 47.4 to 99.7	100 percentage of participants Interval 63.1 to 100.0	50 percentage of participants Interval 1.3 to 98.7

SECONDARY outcome

Timeframe: Baseline to day 35

Population: Participants who received C62-M4 or C1C62-M3M4 vaccines were included. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups.

Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-1) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 35 was measured by ex vivo interferon (IFN)-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm).

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=8 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo Placebo administered on Day 0 and Day 28
Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen	1.15 log2 fold change Interval 0.32 to 1.92	1.66 log2 fold change Interval 1.29 to 2.26	—

SECONDARY outcome

Timeframe: Baseline to day 35

Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-2) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 35 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm).

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=8 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo Placebo administered on Day 0 and Day 28
Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen	1.79 log2 fold change Interval 1.06 to 1.92	1.66 log2 fold change Interval 1.16 to 2.26	—

SECONDARY outcome

Timeframe: Baseline to day 42

Population: Participants who received C62-M4 or C1C62-M3M4 vaccines were included. One participant in the C1C62-M3M4 arm missed the collection visit at day 42 and was unevaluable for this outcome. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups.

Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-1) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 42 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm).

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=7 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo Placebo administered on Day 0 and Day 28
Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen	1.09 log2 fold change Interval 0.5 to 1.89	2.00 log2 fold change Interval 1.03 to 3.47	—

SECONDARY outcome

Timeframe: Baseline to day 42

Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-2) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 42 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm).

Outcome measures

Outcome measures
Measure	C62-M4 n=8 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=7 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo Placebo administered on Day 0 and Day 28
Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen	1.57 log2 fold change Interval 1.06 to 1.89	1.78 log2 fold change Interval 0.96 to 3.47	—

SECONDARY outcome

Timeframe: Baseline to day 56

Population: Participants that received the C62-M4 or C1C62-M3M4 vaccines were included. However, sufficient sample volume at day 56 was available for 2 participants in the C62-M4 arm and 4 participants in the C1C62-M3M4 arm; only the pooled analysis across C62-M4/C1C62-M3M4 was reported. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups.

Change in breadth of T-cell response was measured as the difference in the number of ex vivo reactive subpools (P076, PP077, PP078, PP079, PP080) from baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) to post-vaccination (day 56). The difference in reactive subpools within participants (per vaccinated arm) was estimated and the median value was evaluated using a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm).

Outcome measures

Outcome measures
Measure	C62-M4 n=2 Participants C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=4 Participants C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo Placebo administered on Day 0 and Day 28
Median Change in Breadth of T-cell Responses Targeting Conserved HIV-1 Immunogen Subpools	1.0 subpools Interval 0.5 to 1.5	2.0 subpools Interval 1.25 to 2.5	—

Adverse Events

C62-M4

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

C1C62-M3M4

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Cynthia Gay, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-843-2726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	C62-M4 n=8 participants at risk C62 vaccine administered at Day 0, followed by M4 vaccine administered at Day 28	C1C62-M3M4 n=8 participants at risk C1 and C62 vaccines administered at Day 0, followed by M3 and M4 vaccines administered at Day 28	Placebo n=2 participants at risk Placebo administered on Day 0 and Day 28
Ear and labyrinth disorders Ear pain	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Gastrointestinal disorders Anal fissure	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Gastrointestinal disorders Colitis	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Chills	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	50.0% 4/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Fatigue	75.0% 6/8 • Number of events 11 • From time participants received the study intervention through Day 196.	75.0% 6/8 • Number of events 12 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
General disorders Injection site erythema	25.0% 2/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Injection site induration	12.5% 1/8 • Number of events 3 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Injection site pain	62.5% 5/8 • Number of events 27 • From time participants received the study intervention through Day 196.	100.0% 8/8 • Number of events 50 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
General disorders Injection site swelling	25.0% 2/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Injection site pruritus	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 2 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Injection site warmth	0.00% 0/8 • From time participants received the study intervention through Day 196.	25.0% 2/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Malaise	25.0% 2/8 • Number of events 4 • From time participants received the study intervention through Day 196.	50.0% 4/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
General disorders Pyrexia	25.0% 2/8 • Number of events 2 • From time participants received the study intervention through Day 196.	37.5% 3/8 • Number of events 3 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Gastrointestinal disorders Gingival swelling	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Gastrointestinal disorders Nausea	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Infections and infestations Abscess jaw	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Infections and infestations COVID-19	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Infections and infestations Herpes simplex	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
Infections and infestations Influenza	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Infections and infestations Molluscum contagiosum	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Infections and infestations Viral diarrhoea	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Injury, poisoning and procedural complications Cartilage injury	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Injury, poisoning and procedural complications Procedural hypertension	37.5% 3/8 • Number of events 3 • From time participants received the study intervention through Day 196.	25.0% 2/8 • Number of events 2 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/8 • From time participants received the study intervention through Day 196.	25.0% 2/8 • Number of events 2 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Injury, poisoning and procedural complications Rib fracture	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Injury, poisoning and procedural complications Tendon injury	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Investigations Blood HIV RNA increased	25.0% 2/8 • Number of events 3 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Investigations Blood glucose increased	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	25.0% 2/8 • Number of events 4 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Investigations Blood glucose decreased	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
Investigations Glomerular filtration rate decreased	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 2 • From time participants received the study intervention through Day 196.
Metabolism and nutrition disorders Decreased appetite	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	37.5% 3/8 • Number of events 3 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	50.0% 4/8 • Number of events 6 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Musculoskeletal and connective tissue disorders Osteoarthritis	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Musculoskeletal and connective tissue disorders Pain in jaw	12.5% 1/8 • Number of events 2 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Musculoskeletal and connective tissue disorders Tendon disorder	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/8 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • From time participants received the study intervention through Day 196.	87.5% 7/8 • Number of events 9 • From time participants received the study intervention through Day 196.	50.0% 1/2 • Number of events 1 • From time participants received the study intervention through Day 196.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • From time participants received the study intervention through Day 196.	12.5% 1/8 • Number of events 1 • From time participants received the study intervention through Day 196.	0.00% 0/2 • From time participants received the study intervention through Day 196.