Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]

Table 1 Participant timeline

Visit #	V0	V1	Home visits	V2	V3	V4	V5
Study day	−14 to −1	0	1 to 13	7	14	42	180
Visit window (days)	-	-	-	+2	+3	+14	+28
Written informed consent	X
History and physical examination	X	X		X	X	X	X
Vital signs and anthropometry	X	X		X	X	X	X
Screening and safety labs	X			X	X^a
Serum pregnancy test^b	X
Urinary pregnancy test^b		X					X
Malaria rapid diagnostic test/blood film	X	X
Immunogenicity blood samples	X					X	X
Final confirmation of eligibility		X
Randomization and study product administration		X
Solicited local and systemic AE data collection		X	X	X	X
Unsolicited AE collection		X	X	X	X	X	X
EPI vaccine administration^c						X
T-cell responses — exploratory	X			X		X	X
Participant/parent experience — exploratory		X X^d			X	X
End of study							X‖

^aAdult cohort only; ^badult females only; ^ctoddlers and infants will be administered the other EPI vaccines due at 15 to 18 months and 9 to 10 months/12 months respectively at V4 (day 42);^dpre-vaccination (may also be conducted at V0) and post-vaccination; ‖toddlers and infants will be administered an additional SC dose of a measles and rubella vaccine on or after the end of study visit outside the current protocol to ensure protection based on the current EPI schedule in The Gambia

ISSN: 1745-6215