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NCT06127693: CAIR
Childhood Adversity, Inflammatory Reactivity and Persistent Pain
trial testing Tetravalent Influenza Vaccine in Chronic Pain in 101 participants. Completed in 20 September 2023.
20 September 2023
Quick facts
| Lead sponsor | University of Cape Town |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 101 |
| Start date | 21 June 2022 |
| Primary completion | 20 September 2023 |
| Estimated completion | 20 September 2023 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- Tetravalent Influenza Vaccine — full drug profile →
- High-frequency electrical stimulation
Conditions studied
- Chronic Pain — all drugs for Chronic Pain →
- Central Sensitisation — all drugs for Central Sensitisation →
- Immune Response — all drugs for Immune Response →
- Adverse Childhood Experiences — all drugs for Adverse Childhood Experiences →
Sponsor
University of Cape Town
Who can join
Adults 18 to 65, any sex, with Chronic Pain or Central Sensitisation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to investigate how adverse experiences during childhood are linked to people experiencing persistent pain and fatigue in adulthood. The questions the investigators aim to answer are: 1. Does participant-reported childhood adversity predict levels of IL-6 and TNF-α after in vitro provocation of whole blood using endotoxin? 2. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo immune provocation (tetravalent influenza vaccine)? 3. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo neural provocation? For this study, the investigators will recruit and enrol 96 healthy human adults (18 - 65 years old) with a range of adverse experiences during childhood. Participants will attend 2 study sessions during which the investigators will take a sample of blood, assess pressure pain threshold before and after cold water immersion, assess heart rate variability, and assess the surface area of secondary skin hypersensitivity after electrical stimulation. At the end of the first session, participants will receive the influenza vaccination.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Inflammatory reactivity is unrelated to childhood adversity or provoked modulation of nociception.
Bedwell GJ, Mqadi L, Kamerman P, Hutchinson MR, et al · · 2025 · cited 3× · PMID 40372281 · DOI 10.1097/j.pain.0000000000003658
Verify or expand the search:
- PubMed search for NCT06127693
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Cape Town trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06127693 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cape Town
- Last refreshed: 13 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06127693.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing