Incidence and follow-up of inflammatory cardiac complications after smallpox vaccination11The views expressed in this study are those of the authors and do not reflect the official policy or position of the U.S. government.

Eckart, Robert E.; Love, Suzanne S; Atwood, J. Edwin; Arness, M K; Cassimatis, Dimitri C.; Campbell, Charles L.; Boyd, Sheri Y. N.; Murphy, Joseph G.; Swerdlow, David L.; Collins, Limone; Riddle, James R.; Tornberg, David N; Grabenstein, John D.; Engler, Renata J.M.

doi:10.1016/j.jacc.2004.05.004

Cited by 170 publications

(28 citation statements)

References 15 publications

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“…In addition, active hepatitis B infection and syphilis were excluded at the first screening visit. Twelve-lead electrocardiograms (ECG) were performed before and two weeks after the HIV-MVA/placebo immunizations in order to comply with current US-FDA recommendations to monitor for potential peri-myocarditis due to MVA [40,41]. …”

Section: Methodsmentioning

confidence: 99%

Broad and potent immune responses to a low dose intradermal HIV-1 DNA boosted with HIV-1 recombinant MVA among healthy adults in Tanzania

Bakari

Aboud

Nilsson

et al. 2011

Vaccine

123

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Background We conducted a phase I/II randomized placebo-controlled trial with the aim of exploring whether priming with a low intradermal dose of a multiclade, multigene HIV-1 DNA vaccine could improve the immunogenicity of the same vaccine given intramuscularly prior to boosting with a heterologous HIV-1 MVA among healthy adults in Dar es Salaam, Tanzania. Methods Sixty HIV-uninfected volunteers were randomized to receive DNA plasmid vaccine 1 mg intradermally (id), n = 20, or 3.8 mg intramuscularly (im), n = 20, or placebo, n = 20, using a needle-free injection device. DNA plasmids encoding HIV-1 genes gp160 subtype A, B, C; rev B; p17/p24 gag A, B and Rtmut B were given at weeks 0, 4 and 12. Recombinant MVA (108 pfu) expressing HIV-1 Env, Gag, Pol of CRF01_AE or placebo was administered im at month 9 and 21. Results The vaccines were well tolerated. Two weeks after the third HIV-DNA injection, 22/38 (58%) vaccinees had IFN-γ ELISpot responses to Gag. Two weeks after the first HIV-MVA boost all 35 (100%) vaccinees responded to Gag and 31 (89%) to Env. Two to four weeks after the second HIV-MVA boost, 28/29 (97%) vaccinees had IFN-γ ELISpot responses, 27 (93%) to Gag and 23 (79%) to Env. The id-primed recipients had significantly higher responses to Env than im recipients. Intracellular cytokine staining for Gag-specific IFN-γ/IL-2 production showed both CD8+ and CD4+ T cell responses. All vaccinees had HIV-specific lymphoproliferative responses. All vaccinees reacted in diagnostic HIV serological tests and 26/29 (90%) had antibodies against gp160 after the second HIV-MVA boost. Furthermore, while all of 29 vaccinee sera were negative for neutralizing antibodies against clade B, C and CRF01 AE pseudoviruses in the TZM-bl neutralization assay, in a PBMC assay, the response rate ranged from 31% to 83% positives, depending upon the clade B or CRF01_AE virus tested. This vaccine approach is safe and highly immunogenic. Low dose, id HIV-DNA priming elicited higher and broader cell-mediated immune responses to Env after HIV-MVA boost compared to a higher HIV-DNA priming dose given im. Three HIV-DNA priming immunizations followed by two HIV-MVA boosts efficiently induced Env-antibody responses.

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Section: Methodsmentioning

confidence: 99%

Broad and potent immune responses to a low dose intradermal HIV-1 DNA boosted with HIV-1 recombinant MVA among healthy adults in Tanzania

Bakari

Aboud

Nilsson

et al. 2011

Vaccine

123

View full text Add to dashboard Cite

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“…ECG abnormalities are usually transient and non-specific, whereas several patients have no electrocardiographic abnormalities [10–12]. In fact, some patients with a normal ECG and negative troponin or creatine kinase test may still have (suspected) myocarditis after or during a viral infection of the respiratory or gastrointestinal tract [13, 14].…”

Section: Introductionmentioning

confidence: 99%

Diagnosis of early myocarditis after respiratory or gastrointestinal tract viral infection: insights from cardiovascular magnetic resonance

et al. 2010

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BackgroundThe diagnosis of myocarditis continues to be a challenging task in clinical practice. The purpose of our study was to investigate cardiovascular magnetic resonance imaging in the diagnostic workup of ambulatory patients with the suspicion of early myocarditis after respiratory or gastrointestinal tract viral infection. The need for accurate diagnosis of early myocarditis arises from the low diagnostic accuracy of routine clinical tests.MethodsWe examined 67 consecutive patients with symptoms of weakness, palpitations, and fatigue after respiratory or gastrointestinal tract infection. We compared these patients to 31 controls. ECG-triggered, T2-weighted, fast-spin-echo triple inversion recovery sequences and delayed enhancement imaging were obtained in all patients, as well as functional parameters of left ventricular function and dimensions. In addition, in 25 patients and 10 controls, ECG-triggered, T1-weighted, multi-slice spin-echo images were obtained in axial orientation.ResultsWe found a significant difference between patients with suspected myocarditis and controls in T2-global myocardial signal intensity. In addition, the ratio of global myocardial signal intensity/muscle signal intensity was 2.3 ± 0.4 in patients and 1.8 ± 0.3 in controls, which was highly significant (p < 0.001). In 23 patients, a pathological late enhancement pattern was seen, but only in one of the controls. There was no significant difference in T1-signal parameters.ConclusionCardiovascular magnetic resonance technique is able to detect early myocardial involvement after respiratory or gastrointestinal tract infection.

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“…Although ALVAC-HIV is not a vaccinia-derived vaccine, none of the vaccinated individuals presented post vaccination symptoms suggestive of myopericarditis events as described after smallpox vaccination [48], [49].…”

Section: Discussionmentioning

confidence: 98%

Safety and Reactogenicity of Canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E Vaccination in an Efficacy Trial in Thailand

et al. 2011

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BackgroundA prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand.Methodology/Principal FindingsReactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days.Conclusions/SignificanceThe ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand.Trial Registration ClinicalTrials.gov NCT00223080

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Incidence and follow-up of inflammatory cardiac complications after smallpox vaccination11The views expressed in this study are those of the authors and do not reflect the official policy or position of the U.S. government.

Abstract: Post-vaccinial myopericarditis should be considered in patients with chest pain within 30 days after smallpox vaccination. Normalization of echocardiography, electrocardiography, and treadmill testing is expected, and nearly all patients have resolution of chest pain on follow-up.

Cited by 170 publications

References 15 publications

Broad and potent immune responses to a low dose intradermal HIV-1 DNA boosted with HIV-1 recombinant MVA among healthy adults in Tanzania

Broad and potent immune responses to a low dose intradermal HIV-1 DNA boosted with HIV-1 recombinant MVA among healthy adults in Tanzania

Diagnosis of early myocarditis after respiratory or gastrointestinal tract viral infection: insights from cardiovascular magnetic resonance

Safety and Reactogenicity of Canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E Vaccination in an Efficacy Trial in Thailand

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