لقاح الإيبولا (rVSV-ZEBOV)

العاملون في مجال الصحة في مناطق تفشي الإيبولا، والمخالطون للمصابين المؤكدين، والمسافرون إلى مناطق التفشي النشط.

Severe allergic reaction (anaphylaxis) to a previous dose or any component (including rice protein). Acute febrile illness (defer). Pregnancy — limited data; use only when benefit clearly outweighs risk during active outbreaks. Breastfeeding — viral shedding in breast milk reported; weigh risk-benefit. Not recommended for severely immunocompromised individuals (live vaccine).

Very common (≥1/10): injection site pain (70%), headache (37%), fever (34%), fatigue (19%), myalgia (33%), arthralgia (18%), nausea (18%). Common: joint swelling (4%), rash, excessive sweating. Self-limiting arthritis reported in 4–24% (Prevail I trial). VSV viremia detectable in blood for 1–3 days post-vaccination (not associated with clinical disease). Rare: vasculitis, dermatitis.

Single 1.0 mL dose, intramuscular injection in the deltoid. No booster currently recommended (humoral response durable ≥2 years in clinical data). Administer as soon as possible when outbreak risk identified. Cold chain: store at -80°C to -60°C; stable at +2°C to +8°C for up to 14 days after thawing.

Ring vaccination study (DRC, Ebola ça Suffit! trial, Lancet 2017): 100% efficacy (95% CI 68.9–100.0%) with immediate vaccination (0 cases in vaccinated ring vs. 16 in delayed ring). Antibody response: ≥95% seroconversion at day 28. Durability: neutralizing antibodies detectable at 2 years in ≥90% of vaccinees.

Store at -80°C to -60°C (ultra-cold chain). After thawing: stable at +2°C to +8°C for up to 14 days. Do not refreeze. Protect from light. Use within 4 hours after removal from cold chain at room temperature.

Do not co-administer with other live vaccines unless data supports it — standard spacing (same day or ≥28 days) applies. Limited data on interaction with antimalarials. Immunosuppressive therapy may reduce response (live vaccine). No formal drug interaction studies completed.

Pregnancy: limited human data. Animal studies (reproductive toxicity): no adverse fetal effects. During DRC outbreak, inadvertent vaccination of pregnant women did not show increased adverse outcomes (post-hoc analysis). Use during active outbreak when benefit outweighs risk. Breastfeeding: rVSV detected in breast milk in some recipients — consider temporary cessation (7–14 days).

Not approved for <18 years (Ervebo). Alternative: Zabdeno (Ad26.ZEBOV) + Mvabea (MVA-BN-Filo) 2-dose heterologous regimen approved in EU for ≥1 year. Limited safety data in children <2 years.

Live vaccine — contraindicated in severe immunodeficiency. Vaccine virus shedding occurs (blood 1–3 days, urine up to 14 days, saliva 7 days). Contact precautions in healthcare settings for 14 days post-vaccination. Not for individuals <18 years (Zabdeno/Mvabea 2-dose regimen available for ≥1 year in EU). Vesicular lesions at injection site possible — cover until healed.